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Trial record 29 of 677 for:    amyotrophic lateral sclerosis

Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447952
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Amyotrophic Lateral Sclerosis
Interventions Device: Faros Sensor (FS) and LifeInsight Hub
Device: Fast Fix electrode patch
Procedure: Quantitative Measure of Speech (Core Phase Only)
Enrollment 25
Recruitment Details This is an exploratory, non-controlled, non-drug study in participants with amyotrophic lateral sclerosis (ALS). The study enrolled participants using two sites based in the United Kingdom
Pre-assignment Details Of total 25 screened participants, 5 participants were included in pilot phase of which 2 completed and entered core study phase with other 23 participants.
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Period Title: Overall Study
Started 25
Completed 18
Not Completed 7
Reason Not Completed
Adverse Event             2
Physician Decision             1
Withdrawal by Subject             4
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
53.1  (9.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
4
  16.0%
Male
21
  84.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Asian - East Asian Heritage 1
Asian - South East Asian Heritage 1
White - White/Caucasian/European Heritage 23
1.Primary Outcome
Title Duration of Day Time Wear Time of the Device
Hide Description Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent [Active + lying + sedentary not lying] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was <=1.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants with at least one post Baseline measure for the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and at least one physical activity/movement measure.
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Minutes
Week 0, Day 1, n=24 Number Analyzed 24 participants
718.536  (190.4933)
Week 0, Day 2, n=24 Number Analyzed 24 participants
730.882  (216.3616)
Week 0, Day 3, n=23 Number Analyzed 23 participants
653.980  (241.0427)
Week 0, Day 4, n=12 Number Analyzed 12 participants
207.263  (275.7507)
Week 0, Day 5, n=2 Number Analyzed 2 participants
342.830  (240.4163)
Week4, Day 1, n=22 Number Analyzed 22 participants
762.680  (228.5267)
Week4, Day 2, n=22 Number Analyzed 22 participants
778.636  (169.6978)
Week4, Day 3, n=21 Number Analyzed 21 participants
605.334  (319.5373)
Week4, Day 4, n=9 Number Analyzed 9 participants
207.092  (293.8405)
Week4, Day 5, n=5 Number Analyzed 5 participants
137.600  (300.5371)
Week4, Day 6, n=1 Number Analyzed 1 participants
657.500 [1]   (NA)
Week4, Day 7, n=1 Number Analyzed 1 participants
820.660 [1]   (NA)
Week4, Day 8, n=1 Number Analyzed 1 participants
34.000 [1]   (NA)
Week8, Day 1, n=19 Number Analyzed 19 participants
647.735  (291.5468)
Week8, Day 2, n=17 Number Analyzed 17 participants
744.028  (158.3890)
Week8, Day 3, n=17 Number Analyzed 17 participants
581.939  (297.5053)
Week8, Day 4, n=8 Number Analyzed 8 participants
94.709  (126.7088)
Week12,Day 1, n=16 Number Analyzed 16 participants
552.668  (315.5227)
Week12,Day 2, n=16 Number Analyzed 16 participants
801.697  (170.8600)
Week12,Day 3, n=15 Number Analyzed 15 participants
563.311  (298.3566)
Week12,Day 4, n=7 Number Analyzed 7 participants
425.336  (266.8420)
Week12,Day 5, n=1 Number Analyzed 1 participants
858.660 [1]   (NA)
Week16,Day 1, n=13 Number Analyzed 13 participants
759.399  (129.2502)
Week16,Day 2, n=13 Number Analyzed 13 participants
812.345  (200.5683)
Week16,Day 3, n=12 Number Analyzed 12 participants
631.484  (296.3050)
Week16,Day 4, n=6 Number Analyzed 6 participants
254.500  (336.6649)
Week20,Day 1, n=14 Number Analyzed 14 participants
774.049  (240.7234)
Week20,Day 2, n=13 Number Analyzed 13 participants
648.268  (291.9654)
Week20,Day 3, n=12 Number Analyzed 12 participants
615.277  (239.5376)
Week20,Day 4, n=4 Number Analyzed 4 participants
172.793  (345.3584)
Week24,Day 1, n=14 Number Analyzed 14 participants
505.976  (296.3016)
Week24,Day 2, n=12 Number Analyzed 12 participants
617.599  (299.5749)
Week24,Day 3, n=11 Number Analyzed 11 participants
481.698  (333.5209)
Week24,Day 4, n=8 Number Analyzed 8 participants
306.500  (303.9026)
Week24,Day 5, n=2 Number Analyzed 2 participants
287.000  (184.7953)
Week28,Day 1, n=10 Number Analyzed 10 participants
690.898  (178.9577)
Week28,Day 2, n=10 Number Analyzed 10 participants
722.551  (248.5576)
Week28,Day 3, n=9 Number Analyzed 9 participants
588.464  (359.3972)
Week28,Day 4, n=6 Number Analyzed 6 participants
357.220  (363.2050)
Week32,Day 1, n=12 Number Analyzed 12 participants
575.303  (322.1123)
Week32,Day 2, n=10 Number Analyzed 10 participants
592.866  (345.4597)
Week32,Day 3, n=9 Number Analyzed 9 participants
599.778  (351.8631)
Week32,Day 4, n=1 Number Analyzed 1 participants
32.000 [1]   (NA)
Week36,Day 1, n=12 Number Analyzed 12 participants
510.209  (381.7060)
Week36,Day 2, n=9 Number Analyzed 9 participants
507.872  (397.7501)
Week36,Day 3, n=6 Number Analyzed 6 participants
465.583  (340.8965)
Week36,Day 4, n=4 Number Analyzed 4 participants
387.750  (424.1863)
Week36,Day 5, n=2 Number Analyzed 2 participants
516.250  (454.3161)
Week36,Day 6, n=1 Number Analyzed 1 participants
171.840 [1]   (NA)
Week40,Day 1, n=12 Number Analyzed 12 participants
722.708  (239.1189)
Week40,Day 2, n=12 Number Analyzed 12 participants
618.555  (326.7927)
Week40,Day 3, n=11 Number Analyzed 11 participants
601.665  (312.9329)
Week40,Day 4, n=7 Number Analyzed 7 participants
290.857  (404.5156)
Week40,Day 5, n=1 Number Analyzed 1 participants
823.500 [1]   (NA)
Week40,Day 6, n=1 Number Analyzed 1 participants
444.830 [1]   (NA)
Week44,Day 1, n=12 Number Analyzed 12 participants
746.278  (258.7132)
Week44,Day 2, n=11 Number Analyzed 11 participants
646.452  (295.5684)
Week44,Day 3, n=10 Number Analyzed 10 participants
476.783  (355.1196)
Week44,Day 4, n=4 Number Analyzed 4 participants
178.460  (308.3123)
Week44,Day 5, n=1 Number Analyzed 1 participants
146.660 [1]   (NA)
Week48,Day 1, n=13 Number Analyzed 13 participants
779.438  (120.7527)
Week48,Day 2, n=13 Number Analyzed 13 participants
692.474  (251.7305)
Week48,Day 3, n=10 Number Analyzed 10 participants
622.015  (243.5040)
Week48,Day 4, n=5 Number Analyzed 5 participants
630.000  (380.2256)
[1]
NA indicates that data could not be calculated as participant number was <=1.
2.Other Pre-specified Outcome
Title Duration of Night Time Wear Time of the Device
Hide Description Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent [Active + day time lying + day time “sedentary not lying”] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Minutes
Week 0, Day 1, n=24 Number Analyzed 24 participants
448.174  (222.1658)
Week 0, Day 2, n=24 Number Analyzed 24 participants
360.575  (212.4216)
Week 0, Day 3, n=23 Number Analyzed 23 participants
482.500  (150.8251)
Week 0, Day 4, n=12 Number Analyzed 12 participants
134.570  (239.8401)
Week 0, Day 5, n=2 Number Analyzed 2 participants
494.170  (57.9828)
Week4, Day 1, n=22 Number Analyzed 22 participants
487.682  (189.6054)
Week4, Day 2, n=22 Number Analyzed 22 participants
432.273  (209.9463)
Week4, Day 3, n=21 Number Analyzed 21 participants
455.047  (194.3802)
Week4, Day 4, n=9 Number Analyzed 9 participants
107.796  (205.8403)
Week4, Day 5, n=5 Number Analyzed 5 participants
109.400  (241.1904)
Week4, Day 6, n=1 Number Analyzed 1 participants
624.500 [1]   (NA)
Week4, Day 7, n=1 Number Analyzed 1 participants
462.340 [1]   (NA)
Week4, Day 8, n=1 Number Analyzed 1 participants
0.000 [1]   (NA)
Week8, Day 1, n=19 Number Analyzed 19 participants
506.316  (184.6635)
Week8, Day 2, n=17 Number Analyzed 17 participants
477.441  (206.7924)
Week8, Day 3, n=17 Number Analyzed 17 participants
526.825  (207.6252)
Week8, Day 4, n=8 Number Analyzed 8 participants
30.041  (84.9695)
Week12,Day 1, n=16 Number Analyzed 16 participants
255.708  (250.9718)
Week12,Day 2, n=16 Number Analyzed 16 participants
418.489  (149.6411)
Week12,Day 3, n=15 Number Analyzed 15 participants
519.888  (63.0517)
Week12,Day 4, n=7 Number Analyzed 7 participants
568.381  (150.2560)
Week12,Day 5, n=1 Number Analyzed 1 participants
406.340 [1]   (NA)
Week16,Day 1, n=13 Number Analyzed 13 participants
513.448  (78.9644)
Week16,Day 2, n=13 Number Analyzed 13 participants
382.038  (185.6318)
Week16,Day 3, n=12 Number Analyzed 12 participants
494.932  (196.5556)
Week16,Day 4, n=6 Number Analyzed 6 participants
96.000  (220.5519)
Week20,Day 1, n=14 Number Analyzed 14 participants
445.811  (170.4490)
Week20,Day 2, n=13 Number Analyzed 13 participants
452.345  (203.3159)
Week20,Day 3, n=12 Number Analyzed 12 participants
498.806  (138.8339)
Week20,Day 4, n=4 Number Analyzed 4 participants
148.458  (172.2844)
Week24,Day 1, n=14 Number Analyzed 14 participants
254.095  (261.1246)
Week24,Day 2, n=12 Number Analyzed 12 participants
398.068  (199.7096)
Week24,Day 3, n=11 Number Analyzed 11 participants
374.121  (214.6214)
Week24,Day 4, n=8 Number Analyzed 8 participants
291.376  (277.4058)
Week24,Day 5, n=2 Number Analyzed 2 participants
476.995  (1.8880)
Week28,Day 1, n=10 Number Analyzed 10 participants
497.701  (242.6652)
Week28,Day 2, n=10 Number Analyzed 10 participants
483.950  (195.5384)
Week28,Day 3, n=9 Number Analyzed 9 participants
543.759  (270.4945)
Week28,Day 4, n=6 Number Analyzed 6 participants
286.778  (327.2635)
Week32,Day 1, n=12 Number Analyzed 12 participants
510.447  (218.5192)
Week32,Day 2, n=10 Number Analyzed 10 participants
460.233  (209.0824)
Week32,Day 3, n=9 Number Analyzed 9 participants
433.778  (256.9437)
Week32,Day 4, n=1 Number Analyzed 1 participants
0.000 [1]   (NA)
Week36,Day 1, n=12 Number Analyzed 12 participants
189.124  (199.2290)
Week36,Day 2, n=9 Number Analyzed 9 participants
263.352  (236.3438)
Week36,Day 3, n=6 Number Analyzed 6 participants
380.748  (298.7767)
Week36,Day 4, n=4 Number Analyzed 4 participants
358.503  (280.5689)
Week36,Day 5, n=2 Number Analyzed 2 participants
201.250  (284.6105)
Week36,Day 6, n=1 Number Analyzed 1 participants
505.170 [1]   (NA)
Week40,Day 1, n=12 Number Analyzed 12 participants
375.043  (192.0867)
Week40,Day 2, n=12 Number Analyzed 12 participants
442.528  (179.2818)
Week40,Day 3, n=11 Number Analyzed 11 participants
419.334  (215.0470)
Week40,Day 4, n=7 Number Analyzed 7 participants
121.573  (172.7203)
Week40,Day 5, n=1 Number Analyzed 1 participants
522.500 [1]   (NA)
Week40,Day 6, n=1 Number Analyzed 1 participants
163.170 [1]   (NA)
Week44,Day 1, n=12 Number Analyzed 12 participants
393.140  (192.6969)
Week44,Day 2, n=11 Number Analyzed 11 participants
362.275  (208.9128)
Week44,Day 3, n=10 Number Analyzed 10 participants
382.018  (201.1957)
Week44,Day 4, n=4 Number Analyzed 4 participants
111.543  (223.0850)
Week44,Day 5, n=1 Number Analyzed 1 participants
277.330 [1]   (NA)
Week48,Day 1, n=13 Number Analyzed 13 participants
439.486  (153.3470)
Week48,Day 2, n=13 Number Analyzed 13 participants
381.988  (192.9540)
Week48,Day 3, n=10 Number Analyzed 10 participants
299.985  (146.9104)
Week48,Day 4, n=5 Number Analyzed 5 participants
81.400  (182.0159)
[1]
NA indicates that data could not be calculated as participant number was <=1.
3.Other Pre-specified Outcome
Title Average Time Spent Active
Hide Description Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Minutes
Day time, Week 0, n=24 Number Analyzed 24 participants
34.420  (29.3837)
Day time, Week 4, n=22 Number Analyzed 22 participants
32.233  (33.1012)
Day time, Week 8, n=19 Number Analyzed 19 participants
24.319  (25.5092)
Day time, Week 12, n=16 Number Analyzed 16 participants
23.904  (17.2952)
Day time, Week 16, n=13 Number Analyzed 13 participants
25.863  (23.2673)
Day time, Week 20, n=14 Number Analyzed 14 participants
18.931  (18.3595)
Day time, Week 24, n=14 Number Analyzed 14 participants
12.137  (10.8409)
Day time, Week 28, n=10 Number Analyzed 10 participants
19.856  (29.0562)
Day time, Week 32, n=12 Number Analyzed 12 participants
11.873  (15.0988)
Day time, Week 36, n=12 Number Analyzed 12 participants
14.118  (19.7452)
Day time, Week 40, n=12 Number Analyzed 12 participants
14.563  (18.7912)
Day time, Week 44, n=12 Number Analyzed 12 participants
20.210  (26.0361)
Day time, Week 48, n=13 Number Analyzed 13 participants
23.578  (29.0419)
Night time, Week 0, n=24 Number Analyzed 24 participants
1.136  (1.5427)
Night time, Week 4, n=22 Number Analyzed 22 participants
0.570  (0.6817)
Night time, Week 8, n=19 Number Analyzed 19 participants
2.375  (5.7540)
Night time, Week 12, n=16 Number Analyzed 16 participants
0.484  (0.5404)
Night time, Week 16, n=13 Number Analyzed 13 participants
0.449  (0.4684)
Night time, Week 20, n=14 Number Analyzed 14 participants
0.418  (0.5315)
Night time, Week 24, n=14 Number Analyzed 14 participants
0.387  (0.2715)
Night time, Week 28, n=10 Number Analyzed 10 participants
1.432  (3.0455)
Night time, Week 32, n=12 Number Analyzed 12 participants
0.668  (1.5814)
Night time, Week 36, n=12 Number Analyzed 12 participants
0.414  (0.3682)
Night time, Week 40, n=12 Number Analyzed 12 participants
0.268  (0.3272)
Night time, Week 44, n=12 Number Analyzed 12 participants
0.390  (0.7308)
Night time, Week 48, n=13 Number Analyzed 13 participants
0.518  (0.8014)
4.Other Pre-specified Outcome
Title Average Time Spent 'Sedentary Not Lying'
Hide Description Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Minutes
Day time, Week 0, n=24 Number Analyzed 24 participants
523.191  (113.3016)
Day time, Week 4, n=22 Number Analyzed 22 participants
524.120  (182.7753)
Day time, Week 8, n=19 Number Analyzed 19 participants
428.359  (210.1894)
Day time, Week 12, n=16 Number Analyzed 16 participants
509.634  (105.3263)
Day time, Week 16, n=13 Number Analyzed 13 participants
561.923  (100.3003)
Day time, Week 20, n=14 Number Analyzed 14 participants
489.921  (202.2926)
Day time, Week 24, n=14 Number Analyzed 14 participants
376.117  (222.6009)
Day time, Week 28, n=10 Number Analyzed 10 participants
472.238  (215.7768)
Day time, Week 32, n=12 Number Analyzed 12 participants
420.709  (259.0856)
Day time, Week 36, n=12 Number Analyzed 12 participants
376.686  (233.1990)
Day time, Week 40, n=12 Number Analyzed 12 participants
465.879  (181.5005)
Day time, Week 44, n=12 Number Analyzed 12 participants
440.376  (198.2569)
Day time, Week 48, n=13 Number Analyzed 13 participants
509.536  (171.1560)
Night time, Week 0, n=24 Number Analyzed 24 participants
15.522  (28.5337)
Night time, Week 4, n=22 Number Analyzed 22 participants
10.561  (12.5485)
Night time, Week 8, n=19 Number Analyzed 19 participants
8.441  (5.8601)
Night time, Week 12, n=16 Number Analyzed 16 participants
7.968  (4.8657)
Night time, Week 16, n=13 Number Analyzed 13 participants
8.855  (5.1855)
Night time, Week 20, n=14 Number Analyzed 14 participants
9.239  (6.9942)
Night time, Week 24, n=14 Number Analyzed 14 participants
7.274  (6.5610)
Night time, Week 28, n=10 Number Analyzed 10 participants
17.488  (15.1698)
Night time, Week 32, n=12 Number Analyzed 12 participants
12.930  (14.8779)
Night time, Week 36, n=12 Number Analyzed 12 participants
3.545  (3.5805)
Night time, Week 40, n=12 Number Analyzed 12 participants
8.932  (5.0236)
Night time, Week 44, n=12 Number Analyzed 12 participants
6.321  (4.5166)
Night time, Week 48, n=13 Number Analyzed 13 participants
7.602  (7.4373)
5.Other Pre-specified Outcome
Title Average Time Spent Lying
Hide Description Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Minutes
Day time, Week 0, n=24 Number Analyzed 24 participants
79.027  (59.8512)
Day time, Week 4, n=22 Number Analyzed 22 participants
79.996  (67.1924)
Day time, Week 8, n=19 Number Analyzed 19 participants
90.324  (80.8799)
Day time, Week 12, n=16 Number Analyzed 16 participants
82.146  (59.7457)
Day time, Week 16, n=13 Number Analyzed 13 participants
87.271  (75.4731)
Day time, Week 20, n=14 Number Analyzed 14 participants
89.648  (90.8020)
Day time, Week 24, n=14 Number Analyzed 14 participants
82.979  (89.4852)
Day time, Week 28, n=10 Number Analyzed 10 participants
136.170  (127.2225)
Day time, Week 32, n=12 Number Analyzed 12 participants
99.760  (118.3536)
Day time, Week 36, n=12 Number Analyzed 12 participants
50.278  (48.7456)
Day time, Week 40, n=12 Number Analyzed 12 participants
103.749  (133.3234)
Day time, Week 44, n=12 Number Analyzed 12 participants
71.757  (73.5817)
Day time, Week 48, n=13 Number Analyzed 13 participants
141.575  (140.1450)
Night time, Week 0, n=24 Number Analyzed 24 participants
384.886  (135.8136)
Night time, Week 4, n=22 Number Analyzed 22 participants
384.879  (97.8424)
Night time, Week 8, n=19 Number Analyzed 19 participants
411.110  (157.8820)
Night time, Week 12, n=16 Number Analyzed 16 participants
417.943  (71.9066)
Night time, Week 16, n=13 Number Analyzed 13 participants
413.721  (129.3161)
Night time, Week 20, n=14 Number Analyzed 14 participants
407.060  (175.2092)
Night time, Week 24, n=14 Number Analyzed 14 participants
318.155  (112.8749)
Night time, Week 28, n=10 Number Analyzed 10 participants
454.137  (184.2617)
Night time, Week 32, n=12 Number Analyzed 12 participants
412.196  (170.4452)
Night time, Week 36, n=12 Number Analyzed 12 participants
217.884  (181.3682)
Night time, Week 40, n=12 Number Analyzed 12 participants
355.222  (104.8680)
Night time, Week 44, n=12 Number Analyzed 12 participants
319.022  (155.2519)
Night time, Week 48, n=13 Number Analyzed 13 participants
333.358  (154.9236)
6.Other Pre-specified Outcome
Title Average Time Spent Sedentary.
Hide Description Number of minutes spent sedentary [time spent lying + time spent sedentary not lying] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Minutes
Day time, Week 0, n=24 Number Analyzed 24 participants
602.219  (131.7430)
Day time, Week 4, n=22 Number Analyzed 22 participants
604.116  (165.0799)
Day time, Week 8, n=19 Number Analyzed 19 participants
518.684  (234.6306)
Day time, Week 12, n=16 Number Analyzed 16 participants
591.779  (118.3797)
Day time, Week 16, n=13 Number Analyzed 13 participants
649.195  (117.2721)
Day time, Week 20, n=14 Number Analyzed 14 participants
579.571  (213.9093)
Day time, Week 24, n=14 Number Analyzed 14 participants
459.096  (233.1413)
Day time, Week 28, n=10 Number Analyzed 10 participants
608.409  (141.5444)
Day time, Week 32, n=12 Number Analyzed 12 participants
520.468  (285.7109)
Day time, Week 36, n=12 Number Analyzed 12 participants
426.962  (250.2390)
Day time, Week 40, n=12 Number Analyzed 12 participants
569.629  (171.5586)
Day time, Week 44, n=12 Number Analyzed 12 participants
512.132  (203.0705)
Day time, Week 48, n=13 Number Analyzed 13 participants
651.109  (156.3296)
Night time, Week 0, n=24 Number Analyzed 24 participants
400.408  (132.3420)
Night time, Week 4, n=22 Number Analyzed 22 participants
395.438  (100.9179)
Night time, Week 8, n=19 Number Analyzed 19 participants
419.549  (162.0795)
Night time, Week 12, n=16 Number Analyzed 16 participants
425.909  (69.7741)
Night time, Week 16, n=13 Number Analyzed 13 participants
422.574  (132.3307)
Night time, Week 20, n=14 Number Analyzed 14 participants
416.299  (179.9825)
Night time, Week 24, n=14 Number Analyzed 14 participants
325.427  (114.9446)
Night time, Week 28, n=10 Number Analyzed 10 participants
471.626  (196.1417)
Night time, Week 32, n=12 Number Analyzed 12 participants
425.125  (178.8053)
Night time, Week 36, n=12 Number Analyzed 12 participants
221.430  (184.4017)
Night time, Week 40, n=12 Number Analyzed 12 participants
364.152  (105.2901)
Night time, Week 44, n=12 Number Analyzed 12 participants
325.343  (156.8669)
Night time, Week 48, n=13 Number Analyzed 13 participants
340.960  (157.6860)
7.Other Pre-specified Outcome
Title Time Spent With Sensor Off
Hide Description Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Total Activity Count
Hide Description Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Count of activity
Day time, Week 0, n=24 Number Analyzed 24 participants
3336.550  (2654.406)
Day time, Week 4, n=22 Number Analyzed 22 participants
2903.633  (3059.200)
Day time, Week 8, n=17 Number Analyzed 17 participants
4244.521  (6314.828)
Day time, Week 12, n=16 Number Analyzed 16 participants
2076.129  (1338.276)
Day time, Week 16, n=13 Number Analyzed 13 participants
2216.162  (1732.185)
Day time, Week 20, n=14 Number Analyzed 14 participants
1858.116  (1504.067)
Day time, Week 24, n=13 Number Analyzed 13 participants
1114.152  (683.2223)
Day time, Week 28, n=10 Number Analyzed 10 participants
1468.741  (1559.431)
Day time, Week 32, n=12 Number Analyzed 12 participants
1247.969  (1015.319)
Day time, Week 36, n=12 Number Analyzed 12 participants
1675.754  (1979.210)
Day time, Week 40, n=12 Number Analyzed 12 participants
1542.138  (1421.696)
Day time, Week 44, n=12 Number Analyzed 12 participants
2252.325  (1923.793)
Day time, Week 48, n=13 Number Analyzed 13 participants
1972.506  (2209.802)
Night time, Week 0, n=24 Number Analyzed 24 participants
357.865  (293.7938)
Night time, Week 4, n=22 Number Analyzed 22 participants
265.096  (102.7897)
Night time, Week 8, n=13 Number Analyzed 13 participants
652.108  (1445.624)
Night time, Week 12, n=16 Number Analyzed 16 participants
234.854  (68.8019)
Night time, Week 16, n=13 Number Analyzed 13 participants
254.238  (46.4883)
Night time, Week 20, n=14 Number Analyzed 14 participants
241.504  (68.9048)
Night time, Week 24, n=14 Number Analyzed 14 participants
249.504  (165.5673)
Night time, Week 28, n=10 Number Analyzed 10 participants
328.374  (222.3131)
Night time, Week 32, n=12 Number Analyzed 12 participants
271.988  (189.5221)
Night time, Week 36, n=10 Number Analyzed 10 participants
211.270  (101.4570)
Night time, Week 40, n=12 Number Analyzed 12 participants
212.134  (68.5433)
Night time, Week 44, n=11 Number Analyzed 11 participants
232.571  (117.1910)
Night time, Week 48, n=13 Number Analyzed 13 participants
224.375  (110.9312)
9.Other Pre-specified Outcome
Title Maximum Activity Count in a 24 Hour Period
Hide Description Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Count of activity
Day time, Week 0, n=24 Number Analyzed 24 participants
2803.906  (2819.342)
Day time, Week 4, n=22 Number Analyzed 22 participants
1915.344  (1787.325)
Day time, Week 8, n=17 Number Analyzed 17 participants
3520.196  (6145.555)
Day time, Week 12, n=16 Number Analyzed 16 participants
2004.569  (1341.035)
Day time, Week 16, n=13 Number Analyzed 13 participants
2337.092  (2537.966)
Day time, Week 20, n=14 Number Analyzed 14 participants
1923.578  (1690.000)
Day time, Week 24, n=13 Number Analyzed 13 participants
1050.409  (831.3745)
Day time, Week 28, n=10 Number Analyzed 10 participants
960.596  (667.9179)
Day time, Week 32, n=12 Number Analyzed 12 participants
815.954  (772.5387)
Day time, Week 36, n=12 Number Analyzed 12 participants
1238.367  (1121.657)
Day time, Week 40, n=12 Number Analyzed 12 participants
897.363  (785.0252)
Day time, Week 44, n=12 Number Analyzed 12 participants
1940.100  (2346.428)
Day time, Week 48, n=13 Number Analyzed 13 participants
1647.037  (1645.568)
Night time, Week 0, n=24 Number Analyzed 24 participants
657.385  (823.5054)
Night time, Week 4, n=22 Number Analyzed 22 participants
511.867  (599.0219)
Night time, Week 8, n=19 Number Analyzed 19 participants
676.360  (1168.379)
Night time, Week 12, n=16 Number Analyzed 16 participants
280.178  (222.3819)
Night time, Week 16, n=13 Number Analyzed 13 participants
440.992  (641.4221)
Night time, Week 20, n=13 Number Analyzed 13 participants
306.540  (293.6219)
Night time, Week 24, n=14 Number Analyzed 14 participants
442.779  (611.4870)
Night time, Week 28, n=10 Number Analyzed 10 participants
708.219  (967.2115)
Night time, Week 32, n=12 Number Analyzed 12 participants
479.673  (590.4367)
Night time, Week 36, n=10 Number Analyzed 10 participants
462.395  (313.6826)
Night time, Week 40, n=12 Number Analyzed 12 participants
278.703  (264.5554)
Night time, Week 44, n=11 Number Analyzed 11 participants
383.820  (273.3449)
Night time, Week 48, n=13 Number Analyzed 13 participants
493.870  (524.4698)
10.Other Pre-specified Outcome
Title Mean Maximum Activity Count in a 24 Hour Period
Hide Description Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Count of activity
Day time, Week 0, n=24 Number Analyzed 24 participants
1618.403  (1288.502)
Day time, Week 4, n=22 Number Analyzed 22 participants
1309.195  (1042.150)
Day time, Week 8, n=17 Number Analyzed 17 participants
1612.785  (1822.405)
Day time, Week 12, n=16 Number Analyzed 16 participants
1165.166  (705.7684)
Day time, Week 16, n=13 Number Analyzed 13 participants
1510.868  (1407.533)
Day time, Week 20, n=14 Number Analyzed 14 participants
1146.578  (1016.899)
Day time, Week 24, n=13 Number Analyzed 13 participants
697.693  (678.2212)
Day time, Week 28, n=10 Number Analyzed 10 participants
665.987  (475.5967)
Day time, Week 32, n=12 Number Analyzed 12 participants
633.595  (536.0698)
Day time, Week 36, n=12 Number Analyzed 12 participants
772.909  (672.3572)
Day time, Week 40, n=12 Number Analyzed 12 participants
543.052  (410.3246)
Day time, Week 44, n=12 Number Analyzed 12 participants
1074.333  (988.7887)
Day time, Week 48, n=13 Number Analyzed 13 participants
1002.060  (1011.468)
Night time, Week 0, n=24 Number Analyzed 24 participants
319.872  (312.3125)
Night time, Week 4, n=22 Number Analyzed 22 participants
231.630  (183.2420)
Night time, Week 8, n=19 Number Analyzed 19 participants
518.646  (1153.825)
Night time, Week 12, n=16 Number Analyzed 16 participants
176.211  (142.6990)
Night time, Week 16, n=13 Number Analyzed 13 participants
194.670  (208.1798)
Night time, Week 20, n=13 Number Analyzed 13 participants
174.990  (153.0679)
Night time, Week 24, n=14 Number Analyzed 14 participants
208.871  (184.5488)
Night time, Week 28, n=10 Number Analyzed 10 participants
325.419  (356.4562)
Night time, Week 32, n=12 Number Analyzed 12 participants
267.311  (294.0265)
Night time, Week 36, n=10 Number Analyzed 10 participants
242.772  (159.5699)
Night time, Week 40, n=12 Number Analyzed 12 participants
145.523  (109.5598)
Night time, Week 44, n=11 Number Analyzed 11 participants
207.506  (134.7506)
Night time, Week 48, n=13 Number Analyzed 13 participants
233.548  (215.7070)
11.Other Pre-specified Outcome
Title Number of Continuous Active Periods
Hide Description Active periods were catagorized as >1minute to <=2minutes, >2 minutes to <=5minutes, >5 minutes to <=15 minutes, >15 minutes to <=30 minutes, >30 minutes. Total number of ‘active periods were calculated as 1minute<x<2minutes + ‘number of active periods 2minutes<x<5minutes + ‘number of active periods 5minutes<x<15minutes + ‘number of active periods 15minutes<x<30minutes + ‘number of active periods >30minutes.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Number/Hour
>1 to <=2minutes; Day time, Week 0, n=24 Number Analyzed 24 participants
0.279  (0.3174)
>1 to <=2minutes;Day time, Week 4, n=22 Number Analyzed 22 participants
0.267  (0.3874)
>1 to <=2minutes;Day time, Week 8, n=18 Number Analyzed 18 participants
0.255  (0.3230)
>1 to <=2minutes;Day time, Week 12, n=16 Number Analyzed 16 participants
0.188  (0.1925)
>1 to <=2minutes;Day time, Week 16, n=13 Number Analyzed 13 participants
0.191  (0.1996)
>1 to <=2minutes;Day time, Week 20, n=14 Number Analyzed 14 participants
0.169  (0.1812)
>1 to <=2minutes;Day time, Week 24, n=14 Number Analyzed 14 participants
0.206  (0.2088)
>1 to <=2minutes;Day time, Week 28, n=10 Number Analyzed 10 participants
0.147  (0.1564)
>1 to <=2minutes;Day time, Week 32, n=12 Number Analyzed 12 participants
0.100  (0.1172)
>1 to <=2minutes;Day time, Week 36, n=12 Number Analyzed 12 participants
0.164  (0.2649)
>1 to <=2minutes;Day time, Week 40, n=12 Number Analyzed 12 participants
0.170  (0.2644)
>1 to <=2minutes;Day time, Week 44, n=12 Number Analyzed 12 participants
0.174  (0.2518)
>1 to <=2minutes;Day time, Week 48, n=13 Number Analyzed 13 participants
0.252  (0.3609)
>2 to <=5minutes; Day time, Week 0, n=24 Number Analyzed 24 participants
0.108  (0.1263)
>2 to <=5minutes;Day time, Week 4, n=22 Number Analyzed 22 participants
0.097  (0.1264)
>2 to <=5minutes;Day time, Week 8, n=18 Number Analyzed 18 participants
0.084  (0.1675)
>2 to <=5minutes;Day time, Week 12, n=16 Number Analyzed 16 participants
0.108  (0.1201)
>2 to <=5minutes;Day time, Week 16, n=13 Number Analyzed 13 participants
0.123  (0.1590)
>2 to <=5minutes;Day time, Week 20, n=14 Number Analyzed 14 participants
0.080  (0.1105)
>2 to <=5minutes;Day time, Week 24, n=14 Number Analyzed 14 participants
0.057  (0.0819)
>2 to <=5minutes;Day time, Week 28, n=10 Number Analyzed 10 participants
0.107  (0.1700)
>2 to <=5minutes;Day time, Week 32, n=12 Number Analyzed 12 participants
0.058  (0.1129)
>2 to <=5minutes;Day time, Week 36, n=12 Number Analyzed 12 participants
0.079  (0.1538)
>2 to <=5minutes;Day time, Week 40, n=12 Number Analyzed 12 participants
0.072  (0.1137)
>2 to <=5minutes;Day time, Week 44, n=12 Number Analyzed 12 participants
0.071  (0.1417)
>2 to <=5minutes;Day time, Week 48, n=13 Number Analyzed 13 participants
0.095  (0.1400)
>5 to <=15 minutes; Day time, Week 0, n=24 Number Analyzed 24 participants
0.041  (0.0740)
>5 to <=15 minutes;Day time, Week 4, n=22 Number Analyzed 22 participants
0.030  (0.0471)
>5 to <=15 minutes;Day time, Week 8, n=18 Number Analyzed 18 participants
0.020  (0.0333)
>5 to <=15 minutes;Day time, Week 12, n=16 Number Analyzed 16 participants
0.023  (0.0364)
>5 to <=15 minutes;Day time, Week 16, n=13 Number Analyzed 13 participants
0.042  (0.0699)
>5 to <=15 minutes;Day time, Week 20, n=14 Number Analyzed 14 participants
0.016  (0.0440)
>5 to <=15 minutes;Day time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>5 to <=15 minutes;Day time, Week 28, n=10 Number Analyzed 10 participants
0.024  (0.0534)
>5 to <=15 minutes;Day time, Week 32, n=12 Number Analyzed 12 participants
0.015  (0.0353)
>5 to <=15 minutes;Day time, Week 36, n=12 Number Analyzed 12 participants
0.008  (0.0289)
>5 to <=15 minutes;Day time, Week 40, n=12 Number Analyzed 12 participants
0.022  (0.0549)
>5 to <=15 minutes;Day time, Week 44, n=12 Number Analyzed 12 participants
0.008  (0.0199)
>5 to <=15 minutes;Day time, Week 48, n=13 Number Analyzed 13 participants
0.023  (0.0440)
>15 to <=30 minutes; Day time, Week 0, n=24 Number Analyzed 24 participants
0.003  (0.0108)
>15 to <=30 minutes;Day time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 8, n=18 Number Analyzed 18 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 16, n=13 Number Analyzed 13 participants
0.003  (0.0111)
>15 to <=30 minutes;Day time, Week 20, n=14 Number Analyzed 14 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 28, n=10 Number Analyzed 10 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 32, n=12 Number Analyzed 12 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 36, n=12 Number Analyzed 12 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 44, n=12 Number Analyzed 12 participants
0.000  (0.000)
>15 to <=30 minutes;Day time, Week 48, n=13 Number Analyzed 13 participants
0.000  (0.000)
>30 minutes; Day time, Week 0, n=24 Number Analyzed 24 participants
0.000  (0.000)
>30 minutes;Day time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>30 minutes;Day time, Week 8, n=18 Number Analyzed 18 participants
0.001  (0.0047)
>30 minutes;Day time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>30 minutes;Day time, Week 16, n=13 Number Analyzed 13 participants
0.000  (0.000)
>30 minutes;Day time, Week 20, n=14 Number Analyzed 14 participants
0.000  (0.000)
>30 minutes;Day time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>30 minutes;Day time, Week 28, n=10 Number Analyzed 10 participants
0.000  (0.000)
>30 minutes;Day time, Week 32, n=12 Number Analyzed 12 participants
0.000  (0.000)
>30 minutes;Day time, Week 36, n=12 Number Analyzed 12 participants
0.000  (0.000)
>30 minutes;Day time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>30 minutes;Day time, Week 44, n=12 Number Analyzed 12 participants
0.000  (0.000)
>30 minutes;Day time, Week 48, n=13 Number Analyzed 13 participants
0.000  (0.000)
>1 to <=2minutes; Night time, Week 0, n=24 Number Analyzed 24 participants
0.015  (0.0365)
>1 to <=2minutes;Night time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 8, n=19 Number Analyzed 19 participants
0.046  (0.1453)
>1 to <=2minutes;Night time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 16, n=13 Number Analyzed 13 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 20, n=13 Number Analyzed 13 participants
0.003  (0.0111)
>1 to <=2minutes;Night time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 28, n=10 Number Analyzed 10 participants
0.004  (0.0126)
>1 to <=2minutes;Night time, Week 32, n=12 Number Analyzed 12 participants
0.004  (0.0144)
>1 to <=2minutes;Night time, Week 36, n=10 Number Analyzed 10 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 44, n=11 Number Analyzed 11 participants
0.000  (0.000)
>1 to <=2minutes;Night time, Week 48, n=13 Number Analyzed 13 participants
0.292  (1.0512)
>2 to <=5minutes; Night time, Week 0, n=24 Number Analyzed 24 participants
0.008  (0.0284)
>2 to <=5minutes;Night time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 8, n=19 Number Analyzed 19 participants
0.067  (0.2617)
>2 to <=5minutes;Night time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 16, n=13 Number Analyzed 13 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 20, n=13 Number Analyzed 13 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 28, n=10 Number Analyzed 10 participants
0.006  (0.0190)
>2 to <=5minutes;Night time, Week 32, n=12 Number Analyzed 12 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 36, n=10 Number Analyzed 10 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 44, n=11 Number Analyzed 11 participants
0.000  (0.000)
>2 to <=5minutes;Night time, Week 48, n=13 Number Analyzed 13 participants
0.000  (0.000)
>5 to <=15 minutes; Night time, Week 0, n=24 Number Analyzed 24 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 8, n=19 Number Analyzed 19 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 16, n=13 Number Analyzed 13 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 20, n=13 Number Analyzed 13 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 28, n=10 Number Analyzed 10 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 32, n=12 Number Analyzed 12 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 36, n=10 Number Analyzed 10 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 44, n=11 Number Analyzed 11 participants
0.000  (0.000)
>5 to <=15 minutes;Night time, Week 48, n=13 Number Analyzed 13 participants
0.000  (0.000)
>15 to <=30 minutes; Night time, Week 0, n=24 Number Analyzed 24 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 8, n=19 Number Analyzed 19 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 16, n=13 Number Analyzed 13 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 20, n=13 Number Analyzed 13 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 28, n=10 Number Analyzed 10 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 32, n=12 Number Analyzed 12 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 36, n=10 Number Analyzed 10 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 44, n=11 Number Analyzed 11 participants
0.000  (0.000)
>15 to <=30 minutes;Night time, Week 48, n=13 Number Analyzed 13 participants
0.000  (0.000)
>30 minutes; Night time, Week 0, n=24 Number Analyzed 24 participants
0.000  (0.000)
>30 minutes;Night time, Week 4, n=22 Number Analyzed 22 participants
0.000  (0.000)
>30 minutes;Night time, Week 8, n=19 Number Analyzed 19 participants
0.000  (0.000)
>30 minutes;Night time, Week 12, n=16 Number Analyzed 16 participants
0.000  (0.000)
>30 minutes;Night time, Week 16, n=13 Number Analyzed 13 participants
0.000  (0.000)
>30 minutes;Night time, Week 20, n=13 Number Analyzed 13 participants
0.000  (0.000)
>30 minutes;Night time, Week 24, n=14 Number Analyzed 14 participants
0.000  (0.000)
>30 minutes;Night time, Week 28, n=10 Number Analyzed 10 participants
0.000  (0.000)
>30 minutes;Night time, Week 32, n=12 Number Analyzed 12 participants
0.000  (0.000)
>30 minutes;Night time, Week 36, n=10 Number Analyzed 10 participants
0.000  (0.000)
>30 minutes;Night time, Week 40, n=12 Number Analyzed 12 participants
0.000  (0.000)
>30 minutes;Night time, Week 44, n=11 Number Analyzed 11 participants
0.000  (0.000)
>30 minutes;Night time, Week 48, n=13 Number Analyzed 13 participants
0.000  (0.000)
12.Other Pre-specified Outcome
Title Percent of Time Lying Down at Night
Hide Description Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Percentage of time
Day time, Week 0, n=24 Number Analyzed 24 participants
12.079  (8.3771)
Day time, Week 4, n=22 Number Analyzed 22 participants
14.119  (13.8340)
Day time, Week 8, n=18 Number Analyzed 18 participants
17.993  (12.7684)
Day time, Week 12, n=16 Number Analyzed 16 participants
13.101  (9.7891)
Day time, Week 16, n=13 Number Analyzed 13 participants
12.400  (9.3903)
Day time, Week 20, n=14 Number Analyzed 14 participants
21.198  (25.9982)
Day time, Week 24, n=14 Number Analyzed 14 participants
23.608  (28.1925)
Day time, Week 28, n=10 Number Analyzed 10 participants
23.603  (23.9283)
Day time, Week 32, n=12 Number Analyzed 12 participants
26.613  (34.2248)
Day time, Week 36, n=12 Number Analyzed 12 participants
21.823  (28.2251)
Day time, Week 40, n=12 Number Analyzed 12 participants
17.453  (19.6178)
Day time, Week 44, n=12 Number Analyzed 12 participants
20.397  (26.7615)
Day time, Week 48, n=13 Number Analyzed 13 participants
20.966  (20.3006)
Night time, Week 0, n=24 Number Analyzed 24 participants
95.131  (8.2933)
Night time, Week 4, n=22 Number Analyzed 22 participants
97.280  (2.9257)
Night time, Week 8, n=19 Number Analyzed 19 participants
96.871  (4.0262)
Night time, Week 12, n=16 Number Analyzed 16 participants
97.886  (1.4457)
Night time, Week 16, n=13 Number Analyzed 13 participants
97.817  (1.1466)
Night time, Week 20, n=13 Number Analyzed 13 participants
97.739  (1.1617)
Night time, Week 24, n=14 Number Analyzed 14 participants
97.522  (1.6446)
Night time, Week 28, n=10 Number Analyzed 10 participants
96.397  (2.1777)
Night time, Week 32, n=12 Number Analyzed 12 participants
95.519  (6.0885)
Night time, Week 36, n=10 Number Analyzed 10 participants
98.165  (0.6796)
Night time, Week 40, n=12 Number Analyzed 12 participants
97.293  (1.8971)
Night time, Week 44, n=11 Number Analyzed 11 participants
97.719  (1.6543)
Night time, Week 48, n=13 Number Analyzed 13 participants
93.912  (14.0863)
13.Other Pre-specified Outcome
Title Number of Night Time Movement Episodes Per Hour
Hide Description Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Number of movements/hour
Week 0, n=24 Number Analyzed 24 participants
6.129  (4.6585)
Week 4, n=22 Number Analyzed 22 participants
6.982  (7.6835)
Week 8, n=19 Number Analyzed 19 participants
9.258  (17.3296)
Week 12, n=16 Number Analyzed 16 participants
3.803  (1.7339)
Week 16, n=13 Number Analyzed 13 participants
6.852  (11.6765)
Week 20, n=13 Number Analyzed 13 participants
4.788  (4.4738)
Week 24, n=14 Number Analyzed 14 participants
4.216  (1.8617)
Week 28, n=10 Number Analyzed 10 participants
5.295  (5.1177)
Week 32, n=12 Number Analyzed 12 participants
8.708  (12.9217)
Week 36, n=10 Number Analyzed 10 participants
12.149  (17.7170)
Week 40, n=12 Number Analyzed 12 participants
4.747  (4.5737)
Week 44, n=11 Number Analyzed 11 participants
3.385  (1.8031)
Week 48, n=13 Number Analyzed 13 participants
7.209  (13.6287)
14.Other Pre-specified Outcome
Title Percent Time Night-time Rest Efficiency
Hide Description Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Percentage of time
Week 0, n=24 Number Analyzed 24 participants
0.986  (0.0125)
Week 4, n=22 Number Analyzed 22 participants
0.982  (0.0270)
Week 8, n=19 Number Analyzed 19 participants
0.976  (0.0498)
Week 12, n=16 Number Analyzed 16 participants
0.991  (0.0044)
Week 16, n=13 Number Analyzed 13 participants
0.986  (0.0156)
Week 20, n=13 Number Analyzed 13 participants
0.987  (0.0118)
Week 24, n=14 Number Analyzed 14 participants
0.991  (0.0053)
Week 28, n=10 Number Analyzed 10 participants
0.986  (0.0165)
Week 32, n=12 Number Analyzed 12 participants
0.978  (0.0322)
Week 36, n=10 Number Analyzed 10 participants
0.971  (0.0468)
Week 40, n=12 Number Analyzed 12 participants
0.987  (0.0156)
Week 44, n=11 Number Analyzed 11 participants
0.992  (0.0040)
Week 48, n=13 Number Analyzed 13 participants
0.978  (0.0536)
15.Other Pre-specified Outcome
Title Rest Fragmentation Index
Hide Description Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=24 Number Analyzed 24 participants
0.132  (0.3384)
Week 4, n=22 Number Analyzed 22 participants
0.649  (2.6064)
Week 8, n=19 Number Analyzed 19 participants
0.096  (0.2579)
Week 12, n=16 Number Analyzed 16 participants
0.036  (0.0316)
Week 16, n=13 Number Analyzed 13 participants
0.291  (0.8315)
Week 20, n=13 Number Analyzed 13 participants
0.086  (0.1581)
Week 24, n=14 Number Analyzed 14 participants
0.129  (0.3213)
Week 28, n=10 Number Analyzed 10 participants
0.113  (0.2836)
Week 32, n=12 Number Analyzed 12 participants
0.507  (1.1908)
Week 36, n=10 Number Analyzed 10 participants
0.437  (1.1594)
Week 40, n=12 Number Analyzed 12 participants
0.541  (1.7070)
Week 44, n=11 Number Analyzed 11 participants
0.041  (0.0259)
Week 48, n=13 Number Analyzed 13 participants
0.391  (1.2979)
16.Other Pre-specified Outcome
Title Average Duration of Night Time Movement Episodes
Hide Description Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Seconds
Week 0, n=24 Number Analyzed 24 participants
8.257  (2.5147)
Week 4, n=22 Number Analyzed 22 participants
7.664  (2.0949)
Week 8, n=19 Number Analyzed 19 participants
8.133  (2.8630)
Week 12, n=16 Number Analyzed 16 participants
8.203  (2.3391)
Week 16, n=13 Number Analyzed 13 participants
9.485  (5.4216)
Week 20, n=13 Number Analyzed 13 participants
10.190  (7.2948)
Week 24, n=14 Number Analyzed 14 participants
7.931  (1.8877)
Week 28, n=10 Number Analyzed 10 participants
7.610  (1.5252)
Week 32, n=11 Number Analyzed 11 participants
10.220  (6.3726)
Week 36, n=9 Number Analyzed 9 participants
7.203  (0.6451)
Week 40, n=11 Number Analyzed 11 participants
8.025  (1.8174)
Week 44, n=11 Number Analyzed 11 participants
7.730  (2.3985)
Week 48, n=12 Number Analyzed 12 participants
8.393  (2.5605)
17.Other Pre-specified Outcome
Title Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R
Hide Description Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
0.178
18.Other Pre-specified Outcome
Title Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R
Hide Description Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
-0.426
19.Other Pre-specified Outcome
Title Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R
Hide Description Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
0.049
20.Other Pre-specified Outcome
Title Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R
Hide Description Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
-0.163
21.Other Pre-specified Outcome
Title Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])
Hide Description Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=23 Number Analyzed 23 participants
4.1914  (2.35370)
Week 4, n=21 Number Analyzed 21 participants
4.2198  (2.88326)
Week 8, n=15 Number Analyzed 15 participants
4.2393  (2.50840)
Week 12, n=15 Number Analyzed 15 participants
4.2304  (2.13905)
Week 16, n=12 Number Analyzed 12 participants
3.7404  (1.99810)
Week 20, n=12 Number Analyzed 12 participants
4.6210  (3.40720)
Week 24, n=12 Number Analyzed 12 participants
4.2944  (2.43365)
Week 28, n=10 Number Analyzed 10 participants
6.1888  (5.64815)
Week 32, n=10 Number Analyzed 10 participants
5.0398  (3.64394)
Week 36, n=9 Number Analyzed 9 participants
4.9206  (3.44514)
Week 40, n=11 Number Analyzed 11 participants
4.6117  (2.81758)
Week 44, n=11 Number Analyzed 11 participants
3.8315  (2.29689)
Week 48, n=11 Number Analyzed 11 participants
4.4358  (2.56115)
22.Other Pre-specified Outcome
Title Variance of HRV While Lying (LF/HF)
Hide Description Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=23 Number Analyzed 23 participants
6.3439  (6.55782)
Week 4, n=21 Number Analyzed 21 participants
6.8401  (6.49766)
Week 8, n=15 Number Analyzed 15 participants
5.3481  (4.86394)
Week 12, n=15 Number Analyzed 15 participants
11.4190  (11.42238)
Week 16, n=12 Number Analyzed 12 participants
16.1974  (20.59606)
Week 20, n=12 Number Analyzed 12 participants
10.2248  (13.69276)
Week 24, n=12 Number Analyzed 12 participants
6.5774  (9.07676)
Week 28, n=10 Number Analyzed 10 participants
6.6424  (7.53794)
Week 32, n=10 Number Analyzed 10 participants
5.8556  (7.19624)
Week 36, n=9 Number Analyzed 9 participants
15.4940  (30.00587)
Week 40, n=11 Number Analyzed 11 participants
4.5088  (3.56720)
Week 44, n=11 Number Analyzed 11 participants
6.4731  (6.29614)
Week 48, n=11 Number Analyzed 11 participants
11.7375  (13.64105)
23.Other Pre-specified Outcome
Title Mean HRV While Sedentary Not Lying (LF/HF)
Hide Description Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=20 Number Analyzed 20 participants
5.2011  (2.48369)
Week 4, n=18 Number Analyzed 18 participants
5.3944  (2.83547)
Week 8, n=13 Number Analyzed 13 participants
5.1733  (2.29737)
Week 12, n=14 Number Analyzed 14 participants
6.3760  (3.42063)
Week 16, n=11 Number Analyzed 11 participants
6.0905  (3.68543)
Week 20, n=10 Number Analyzed 10 participants
6.0958  (3.05182)
Week 24, n=10 Number Analyzed 10 participants
6.3113  (3.03599)
Week 28, n=9 Number Analyzed 9 participants
5.4652  (3.20703)
Week 32, n=9 Number Analyzed 9 participants
8.3196  (5.37661)
Week 36, n=11 Number Analyzed 11 participants
6.6827  (2.73499)
Week 40, n=9 Number Analyzed 9 participants
4.8166  (2.16486)
Week 44, n=9 Number Analyzed 9 participants
5.6220  (2.61752)
Week 48, n=7 Number Analyzed 7 participants
5.8935  (3.22033)
24.Other Pre-specified Outcome
Title Variance of HRV While Sedentary Not Lying (LF/HF)
Hide Description Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=20 Number Analyzed 20 participants
6.3439  (6.55782)
Week 4, n=18 Number Analyzed 18 participants
6.8401  (6.49766)
Week 8, n=13 Number Analyzed 13 participants
5.3481  (4.86394)
Week 12, n=14 Number Analyzed 14 participants
11.4190  (11.42238)
Week 16, n=11 Number Analyzed 11 participants
16.1974  (20.59606)
Week 20, n=10 Number Analyzed 10 participants
10.2248  (13.69276)
Week 24, n=10 Number Analyzed 10 participants
6.5774  (9.07676)
Week 28, n=9 Number Analyzed 9 participants
6.6424  (7.53794)
Week 32, n=9 Number Analyzed 9 participants
5.8556  (7.19624)
Week 36, n=11 Number Analyzed 11 participants
15.4940  (30.00587)
Week 40, n=9 Number Analyzed 9 participants
4.5088  (3.56720)
Week 44, n=9 Number Analyzed 9 participants
6.4731  (6.29614)
Week 48, n=7 Number Analyzed 7 participants
11.7375  (13.64105)
25.Other Pre-specified Outcome
Title Mean HRV While Active (LF/HF)
Hide Description Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was <=1
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=2 Number Analyzed 2 participants
4.3350  (0.09192)
Week 4, n=1 Number Analyzed 1 participants
3.8100 [1]   (NA)
[1]
Standard deviation could not be calculated when number of participants was <=1
26.Other Pre-specified Outcome
Title Variance of HRV While Active (LF/HF)
Hide Description Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=2 Number Analyzed 2 participants
0.0000  (0.0000)
Week 4, n=1 Number Analyzed 1 participants
0.0000 [1]   (NA)
[1]
NA indicates that data could not be calculated as participant number was <=1
27.Other Pre-specified Outcome
Title Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)
Hide Description The effect of being upright on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=20 Number Analyzed 20 participants
1.0563  (2.12227)
Week 4, n=18 Number Analyzed 18 participants
1.3507  (2.56807)
Week 8, n=13 Number Analyzed 13 participants
1.1937  (2.40299)
Week 12, n=14 Number Analyzed 14 participants
2.1585  (2.80355)
Week 16, n=11 Number Analyzed 11 participants
2.5080  (3.40632)
Week 20, n=10 Number Analyzed 10 participants
2.4613  (3.64555)
Week 24, n=10 Number Analyzed 10 participants
2.5161  (1.95702)
Week 28, n=9 Number Analyzed 9 participants
-0.1964  (6.11226)
Week 32, n=9 Number Analyzed 9 participants
3.3476  (5.59881)
Week 36, n=9 Number Analyzed 9 participants
2.5583  (3.74969)
Week 40, n=9 Number Analyzed 9 participants
0.9722  (1.73768)
Week 44, n=9 Number Analyzed 9 participants
1.6069  (2.71641)
Week 48, n=6 Number Analyzed 6 participants
1.5796  (3.73597)
28.Other Pre-specified Outcome
Title Effect of Being Upright on HRV Variance (LF/HF Analysis)
Hide Description The effect of being upright on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=20 Number Analyzed 20 participants
-0.0750  (5.21420)
Week 4, n=18 Number Analyzed 18 participants
-5.5005  (28.71903)
Week 8, n=13 Number Analyzed 13 participants
-2.0885  (9.89872)
Week 12, n=14 Number Analyzed 14 participants
4.1473  (8.03699)
Week 16, n=11 Number Analyzed 11 participants
9.8909  (21.83721)
Week 20, n=10 Number Analyzed 10 participants
2.9204  (17.31637)
Week 24, n=10 Number Analyzed 10 participants
-1.1979  (2.96892)
Week 28, n=9 Number Analyzed 9 participants
-13.6310  (45.52591)
Week 32, n=9 Number Analyzed 9 participants
-8.9054  (19.69942)
Week 36, n=9 Number Analyzed 9 participants
10.3525  (35.50938)
Week 40, n=9 Number Analyzed 9 participants
-3.8092  (8.66934)
Week 44, n=9 Number Analyzed 9 participants
-2.1221  (11.81571)
Week 48, n=6 Number Analyzed 6 participants
4.3165  (16.66785)
29.Other Pre-specified Outcome
Title Effect of Activity on Mean HRV (LF/HF)
Hide Description The effect of activity on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0; n= 2 Number Analyzed 2 participants
-1.6117  (2.88735)
Week 4; n= 1 Number Analyzed 1 participants
0.9367 [1]   (NA)
[1]
NA indicates that data could not be calculated as participant number was <=1.
30.Other Pre-specified Outcome
Title Effect of Activity on HRV Variance (LF/HF Analysis)
Hide Description The effect of activity on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0; n= 2 Number Analyzed 2 participants
-8.6500  (5.93027)
Week 4; n= 1 Number Analyzed 1 participants
-3.4367 [1]   (NA)
[1]
NA indicates that data could not be calculated as participant number was <=1.
31.Other Pre-specified Outcome
Title Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)
Hide Description Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Milliseconds^2
Week 0, n=24 Number Analyzed 24 participants
21.2445  (6.13882)
Week 4, n=21 Number Analyzed 21 participants
20.0394  (6.61338)
Week 8, n=15 Number Analyzed 15 participants
22.4551  (5.98867)
Week 12, n=16 Number Analyzed 16 participants
20.6744  (6.95469)
Week 16, n=12 Number Analyzed 12 participants
20.7926  (7.01048)
Week 20, n=12 Number Analyzed 12 participants
20.7321  (6.80432)
Week 24, n=12 Number Analyzed 12 participants
21.3250  (6.92749)
Week 28, n=10 Number Analyzed 10 participants
21.7888  (7.14731)
Week 32, n=10 Number Analyzed 10 participants
21.1318  (8.08213)
Week 36, n=11 Number Analyzed 11 participants
20.8849  (5.72665)
Week 40, n=11 Number Analyzed 11 participants
20.0684  (7.98572)
Week 44, n=11 Number Analyzed 11 participants
20.2980  (5.95832)
Week 48, n=12 Number Analyzed 12 participants
19.5152  (8.04882)
32.Other Pre-specified Outcome
Title HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis
Hide Description HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Milliseconds^2
Week 0, n=24 Number Analyzed 24 participants
35.3316  (25.70628)
Week 4, n=21 Number Analyzed 21 participants
26.2719  (19.19169)
Week 8, n=15 Number Analyzed 15 participants
34.5477  (18.01341)
Week 12, n=16 Number Analyzed 16 participants
31.8929  (28.36635)
Week 16, n=12 Number Analyzed 12 participants
34.8321  (25.62477)
Week 20, n=12 Number Analyzed 12 participants
41.4669  (36.88159)
Week 24, n=12 Number Analyzed 12 participants
34.3781  (38.27469)
Week 28, n=10 Number Analyzed 10 participants
45.4243  (62.35269)
Week 32, n=10 Number Analyzed 10 participants
30.5288  (24.91715)
Week 36, n=11 Number Analyzed 11 participants
24.8373  (14.41668)
Week 40, n=11 Number Analyzed 11 participants
18.4227  (9.54924)
Week 44, n=11 Number Analyzed 11 participants
22.5279  (10.78475)
Week 48, n=12 Number Analyzed 12 participants
15.7176  (13.15760)
33.Other Pre-specified Outcome
Title Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R
Hide Description Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient
Time Frame Up to Week 48
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
Mean HRV effect of being upright v/s ALSFRS-R;n=24 Number Analyzed 24 participants
0.139
Mean LF/HF (lying down) (1) v/s ALSFRS-R;n=25 Number Analyzed 25 participants
0.228
Mean LF/HF sedentary (not lying) v/s ALSFRS-R;n=24 Number Analyzed 24 participants
0.023
Var. LF/HF sedentary (not lying) v/s ALSFR-R;n=24 Number Analyzed 24 participants
-0.041
Mean HRV effect of activity v/s ALSFRS-R;n=3 Number Analyzed 3 participants
0.421
Mean LF/HF (avg-daytime activity) v/s ALSFRS-R;n=3 Number Analyzed 3 participants
-0.921
Var of HRV effect of activity v/s ALSFRS-R;n=3 Number Analyzed 3 participants
0.419
Var of HRV effect being upright v/s ALSFRS-R;n=24 Number Analyzed 24 participants
0.308
Var of LF/HF (lying down) v/s ALSFRS-R;n=25 Number Analyzed 25 participants
-0.378
Var of LF/HF v/s ALSFRS-R;n=3 Number Analyzed 3 participants
NA [1] 
[1]
NA indicates that sample size is insufficient to calculate the correlation coefficient
34.Other Pre-specified Outcome
Title Measurement of Speech Quality
Hide Description Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for ‘short ah’ and ‘long ah’ tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Hertz
CTF F0;Week0;n=25 (Short ah) Number Analyzed 25 participants
151.829  (44.5983)
CTF F0;Week12;n=18 (Short ah) Number Analyzed 18 participants
156.506  (42.0801)
CTF F0;Week24;n=17 (Short ah) Number Analyzed 17 participants
143.481  (43.8646)
CTF F0;Week36;n=15 (Short ah) Number Analyzed 15 participants
151.192  (43.1685)
CTF F0;Week48;n=18 (Short ah) Number Analyzed 18 participants
156.418  (71.9125)
CTF F0;EWD;n=3 (Short ah) Number Analyzed 3 participants
176.229  (76.2851)
Jitter;Week0;n=25 (Short ah) Number Analyzed 25 participants
0.405  (0.2814)
Jitter;Week12;n=18 (Short ah) Number Analyzed 18 participants
0.531  (0.2956)
Jitter;Week24;n=17 (Short ah) Number Analyzed 17 participants
0.415  (0.3345)
Jitter;Week36;n=15 (Short ah) Number Analyzed 15 participants
0.429  (0.2987)
Jitter;Week48;n=18 (Short ah) Number Analyzed 18 participants
0.379  (0.2949)
Jitter;EWD;n=2 (Short ah) Number Analyzed 2 participants
0.435  (0.1835)
Shimmer;Week0;n=25 (Short ah) Number Analyzed 25 participants
5.099  (1.0892)
Shimmer;Week12;n=18 (Short ah) Number Analyzed 18 participants
5.031  (1.0850)
Shimmer;Week24;n=17 (Short ah) Number Analyzed 17 participants
5.498  (1.1896)
Shimmer;Week36;n=15 (Short ah) Number Analyzed 15 participants
5.203  (1.4083)
Shimmer;Week48;n=18 (Short ah) Number Analyzed 18 participants
5.157  (1.9564)
Shimmer;EWD;n=2 (Short ah) Number Analyzed 2 participants
5.624  (1.5979)
CTF F0;Week0;n=25 (Long ah) Number Analyzed 25 participants
134.443  (33.2237)
CTF F0;Week12;n=18 (Long ah) Number Analyzed 18 participants
122.620  (35.6641)
CTF F0;Week24;n=17 (Long ah) Number Analyzed 17 participants
146.295  (63.0013)
CTF F0;Week36;n=15 (Long ah) Number Analyzed 15 participants
145.575  (45.5629)
CTF F0;Week48;n=18 (Long ah) Number Analyzed 18 participants
134.198  (48.3046)
CTF F0;EWD;n=3 (Long ah) Number Analyzed 3 participants
179.844  (25.7371)
Jitter;Week0;n=25 (Long ah) Number Analyzed 25 participants
0.148  (0.1701)
Jitter;Week12;n=18 (Long ah) Number Analyzed 18 participants
0.098  (0.0697)
Jitter;Week24;n=17 (Long ah) Number Analyzed 17 participants
0.178  (0.3030)
Jitter;Week36;n=15 (Long ah) Number Analyzed 15 participants
0.229  (0.3069)
Jitter;Week48;n=18 (Long ah) Number Analyzed 18 participants
0.148  (0.1309)
Jitter;EWD;n=2 (Long ah) Number Analyzed 2 participants
0.304  (0.3115)
Shimmer;Week0;n=25 (Long ah) Number Analyzed 25 participants
2.926  (1.0166)
Shimmer;Week12;n=18 (Long ah) Number Analyzed 18 participants
3.192  (0.8599)
Shimmer;Week24;n=17 (Long ah) Number Analyzed 17 participants
3.082  (1.1959)
Shimmer;Week36;n=15 (Long ah) Number Analyzed 15 participants
2.872  (1.2162)
Shimmer;Week48;n=18 (Long ah) Number Analyzed 18 participants
3.046  (1.4476)
Shimmer;EWD;n=2 (Long ah) Number Analyzed 2 participants
2.767  (0.0709)
35.Other Pre-specified Outcome
Title Duration of Maximum Gap Between Words
Hide Description Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.
Time Frame Up to Week 48
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Arm/Group Title Mega Faros Device + Fast Fix
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In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
36.Other Pre-specified Outcome
Title Speaking Rate
Hide Description Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Words per minute
Week0; n=25 Number Analyzed 25 participants
151.490  (42.3137)
Week12; n=18 Number Analyzed 18 participants
160.628  (46.2482)
Week24; n=17 Number Analyzed 17 participants
153.958  (45.2931)
Week36; n=15 Number Analyzed 15 participants
166.342  (67.6138)
Week48; n=18 Number Analyzed 18 participants
138.984  (65.6871)
EWD; n=2 Number Analyzed 2 participants
179.687  (27.6064)
37.Other Pre-specified Outcome
Title Average Phoneme Rate
Hide Description Phoneme rate was analyzed for the single word “doily”. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Hertz per second
Week0; n=25 Number Analyzed 25 participants
6176.377  (2196.778)
Week12; n=18 Number Analyzed 18 participants
6903.574  (2484.952)
Week24; n=17 Number Analyzed 17 participants
5859.531  (3433.272)
Week36; n=15 Number Analyzed 15 participants
6937.497  (4868.936)
Week48; n=18 Number Analyzed 18 participants
5738.519  (3410.358)
EWD; n=2 Number Analyzed 2 participants
8980.240  (709.4459)
38.Other Pre-specified Outcome
Title Maximum Phonation Time
Hide Description Maximum phonation time for the single word “doily” test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Seconds
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Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Seconds
Week0; n=25 Number Analyzed 25 participants
0.174  (0.0724)
Week12; n=18 Number Analyzed 18 participants
0.188  (0.0862)
Week24; n=17 Number Analyzed 17 participants
0.186  (0.1005)
Week36; n=15 Number Analyzed 15 participants
0.154  (0.0608)
Week48; n=18 Number Analyzed 18 participants
0.147  (0.0884)
EWD; n=2 Number Analyzed 2 participants
0.212  (0.0639)
39.Other Pre-specified Outcome
Title Percentage Pause Time
Hide Description Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Percentage of time
Week0; n=25 Number Analyzed 25 participants
31.900  (17.1724)
Week12; n=18 Number Analyzed 18 participants
26.609  (8.1333)
Week24; n=17 Number Analyzed 17 participants
30.177  (14.3137)
Week36; n=15 Number Analyzed 15 participants
24.410  (9.5753)
Week48; n=18 Number Analyzed 18 participants
23.991  (11.8426)
EWD; n=2 Number Analyzed 2 participants
24.042  (0.3466)
40.Other Pre-specified Outcome
Title Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R
Hide Description Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
Jitter (%) (Short ah) v/s ALSFRS-R 0.137
CTF F0 (Long ah) v/s ALSFRS-R -0.154
Jitter (%) (Long ah) v/s ALSFRS-R 0.119
Shimmer(%) (Long ah) v/s ALSFRS-R 0.138
Maximum Phonation Time v/s ALSFRS-R 0.152
41.Other Pre-specified Outcome
Title Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC
Hide Description Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Ratio
CTF F0 (Short ah) v/s FVC -0.214
Jitter (%) (Short ah) v/s FVC 0.143
Shimmer(%) (Short ah) v/s FVC -0.080
CTF F0 (Long ah) v/s FVC -0.504
Jitter (%) (Long ah) v/s FVC -0.321
Shimmer(%) (Long ah) v/s FVC -0.327
Average Phoneme Rate v/s FVC 0.453
Maximum Phonation Time v/s FVC -0.215
Percent Pause Time v/s FVC -0.376
Speaking Rate v/s FVC 0.547
42.Other Pre-specified Outcome
Title Number of Participants Reporting Sensor Comfort
Hide Description Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Sensor comfortable to wear;Pilot; n=5;Yes Number Analyzed 5 participants
4
Sensor comfortable to wear;Pilot; n=5;No Number Analyzed 5 participants
1
Sensor comfortable to wear;Pilot repeat; n=5;Yes Number Analyzed 5 participants
3
Sensor comfortable to wear;Pilot repeat; n=5;No Number Analyzed 5 participants
2
Sensor comfortable to wear;Week12; n=15;Yes Number Analyzed 15 participants
14
Sensor comfortable to wear;Week12; n=15;No Number Analyzed 15 participants
1
Sensor comfortable to wear;Week24; n=14; Yes Number Analyzed 14 participants
13
Sensor comfortable to wear;Week24; n=14;No Number Analyzed 14 participants
1
Sensor comfortable to wear;Week36; n=14; Yes Number Analyzed 14 participants
12
Sensor comfortable to wear;Week36; n=14; No Number Analyzed 14 participants
2
Sensor comfortable to wear;Week48; n=18; Yes Number Analyzed 18 participants
14
Sensor comfortable to wear;Week48; n=18;No Number Analyzed 18 participants
4
Sensor comfortable to wear;EWD; n=2;Yes Number Analyzed 2 participants
0
Sensor comfortable to wear;EWD; n=2;No Number Analyzed 2 participants
2
43.Other Pre-specified Outcome
Title Number of Participants Reporting Impact on Sleep
Hide Description Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Not at all;Pilot; n=5 Number Analyzed 5 participants
4
Moderately;Pilot; n=5 Number Analyzed 5 participants
1
Minimally; Pilot; n=5 Number Analyzed 5 participants
0
Not at all;Pilot repeat; n=5 Number Analyzed 5 participants
3
Moderately;Pilot repeat; n=5 Number Analyzed 5 participants
2
Minimally; Pilot repeat; n=5 Number Analyzed 5 participants
0
Not at all;Week12; n=15 Number Analyzed 15 participants
15
Moderately;Week12; n=15 Number Analyzed 15 participants
0
Minimally; Week12; n=15 Number Analyzed 15 participants
0
Not at all;Week24; n=14 Number Analyzed 14 participants
12
Moderately;Week24; n=14 Number Analyzed 14 participants
0
Minimally; Week24; n=14 Number Analyzed 14 participants
2
Not at all;Week36; n=14 Number Analyzed 14 participants
12
Moderately;Week36; n=14 Number Analyzed 14 participants
0
Minimally; Week36; n=14 Number Analyzed 14 participants
2
Not at all;Week48; n=18 Number Analyzed 18 participants
15
Moderately;Week48; n=18 Number Analyzed 18 participants
0
Minimally; Week48; n=18 Number Analyzed 18 participants
3
Not at all;EWD; n=2 Number Analyzed 2 participants
1
Moderately;EWD; n=2 Number Analyzed 2 participants
1
Minimally; EWD; n=2 Number Analyzed 2 participants
0
44.Other Pre-specified Outcome
Title Number of Participants With Ease of Setting up and Attaching the Sensor
Hide Description The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Easy;Pilot; n=5 Number Analyzed 5 participants
4
Neutral;Pilot; n=5 Number Analyzed 5 participants
1
Difficult;Pilot; n=5 Number Analyzed 5 participants
0
Easy;Pilot repeat; n=5 Number Analyzed 5 participants
5
Neutral;Pilot repeat; n=5 Number Analyzed 5 participants
0
Difficult;Pilot repeat; n=5 Number Analyzed 5 participants
0
Easy;Week0; n=25 Number Analyzed 25 participants
23
Neutral;Week0; n=25 Number Analyzed 25 participants
2
Difficult;Week0; n=25 Number Analyzed 25 participants
0
Easy;Week4; n=23 Number Analyzed 23 participants
23
Neutral;Week4; n=23 Number Analyzed 23 participants
0
Difficult;Week4; n=23 Number Analyzed 23 participants
0
Easy;Week8; n=21 Number Analyzed 21 participants
19
Neutral;Week8; n=21 Number Analyzed 21 participants
0
Difficult;Week8; n=21 Number Analyzed 21 participants
2
Easy;Week12; n=20 Number Analyzed 20 participants
18
Neutral;Week12; n=20 Number Analyzed 20 participants
2
Difficult;Week12; n=20 Number Analyzed 20 participants
0
Easy;Week16; n=18 Number Analyzed 18 participants
15
Neutral;Week16; n=18 Number Analyzed 18 participants
2
Difficult;Week16; n=18 Number Analyzed 18 participants
1
Easy;Week20; n=20 Number Analyzed 20 participants
15
Neutral;Week20; n=20 Number Analyzed 20 participants
2
Difficult;Week20; n=20 Number Analyzed 20 participants
3
Easy;Week24; n=18 Number Analyzed 18 participants
15
Neutral;Week24; n=18 Number Analyzed 18 participants
2
Difficult;Week24; n=18 Number Analyzed 18 participants
1
Easy;Week28; n=16 Number Analyzed 16 participants
12
Neutral;Week28; n=16 Number Analyzed 16 participants
2
Difficult;Week28; n=16 Number Analyzed 16 participants
2
Easy;Week32; n=20 Number Analyzed 20 participants
15
Neutral;Week32; n=20 Number Analyzed 20 participants
3
Difficult;Week32; n=20 Number Analyzed 20 participants
2
Easy;Week36; n=18 Number Analyzed 18 participants
14
Neutral;Week36; n=18 Number Analyzed 18 participants
3
Difficult;Week36; n=18 Number Analyzed 18 participants
1
Easy;Week40; n=15 Number Analyzed 15 participants
10
Neutral;Week40; n=15 Number Analyzed 15 participants
3
Difficult;Week40; n=15 Number Analyzed 15 participants
2
Easy;Week44; n=16 Number Analyzed 16 participants
13
Neutral;Week44; n=16 Number Analyzed 16 participants
1
Difficult;Week44; n=16 Number Analyzed 16 participants
2
Easy;Week48; n=15 Number Analyzed 15 participants
8
Neutral;Week48; n=15 Number Analyzed 15 participants
3
Difficult;Week48; n=15 Number Analyzed 15 participants
4
45.Other Pre-specified Outcome
Title Number of Participants With Corresponding Activity Level Required to Complete Their Job
Hide Description The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Mega Faros Device + Fast Fix
Hide Arm/Group Description:
In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Participants
Pilot; Not working;n=5 Number Analyzed 5 participants
1
Pilot; Physical activity required;n=5 Number Analyzed 5 participants
2
Pilot; Sedentary;n=5 Number Analyzed 5 participants
2
Pilot repeat; Not working;n=5 Number Analyzed 5 participants
1
Pilot Repeat; Physical activity required;n=5 Number Analyzed 5 participants
0
Pilot Repeat; Sedentary;n=5 Number Analyzed 5 participants
4
Week0; Not working;n=25 Number Analyzed 25 participants
10
Week0; Physical activity required;n=25 Number Analyzed 25 participants
10
Week0; Sedentary;n=25 Number Analyzed 25 participants
5
Week4; Not working;n=23 Number Analyzed 23 participants
8
Week4; Physical activity required;n=23 Number Analyzed 23 participants
7
Week4; Sedentary;n=23 Number Analyzed 23 participants
8
Week8; Not working;n=21 Number Analyzed 21 participants
12
Week8; Physical activity required;n=21 Number Analyzed 21 participants
5
Week8; Sedentary;n=21 Number Analyzed 21 participants
4
Week12; Not working;n=20 Number Analyzed 20 participants
8
Week12; Physical activity required;n=20 Number Analyzed 20 participants
5
Week12; Sedentary;n=20 Number Analyzed 20 participants
7
Week16; Not working;n=18 Number Analyzed 18 participants
11
Week16; Physical activity required;n=18 Number Analyzed 18 participants
3
Week16; Sedentary;n=18 Number Analyzed 18 participants
4
Week20; Not working;n=20 Number Analyzed 20 participants
11
Week20; Physical activity required;n=20 Number Analyzed 20 participants
5
Week20; Sedentary;n=20 Number Analyzed 20 participants
4
Week24; Not working;n=18 Number Analyzed 18 participants
11
Week24; Physical activity required;n=18 Number Analyzed 18 participants
4
Week24; Sedentary;n=18 Number Analyzed 18 participants
3
Week28; Not working;n=16 Number Analyzed 16 participants
9
Week28; Physical activity required;n=16 Number Analyzed 16 participants
2
Week28; Sedentary;n=16 Number Analyzed 16 participants
5
Week32; Not working;n=20 Number Analyzed 20 participants
11
Week32; Physical activity required;n=20 Number Analyzed 20 participants
5
Week32; Sedentary;n=20 Number Analyzed 20 participants
4
Week36; Not working;n=18 Number Analyzed 18 participants
11
Week36; Physical activity required;n=18 Number Analyzed 18 participants
3
Week36; Sedentary;n=18 Number Analyzed 18 participants
4
Week40; Not working;n=15 Number Analyzed 15 participants
7
Week40; Physical activity required;n=15 Number Analyzed 15 participants
7
Week40; Sedentary;n