Laser Light Cues for Gait Freezing in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT00320242
• Recruitment Status: Completed
• First Posted: May 3, 2006
• Results First Posted: July 14, 2017
• Last Update Posted: July 14, 2017
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): David K. Simon, Beth Israel Deaconess Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Parkinson's Disease
• Intervention: Device: 1 mo baseline before visual cue
• Enrollment: 32

Participant Flow

Recruitment Details	All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals
Pre-assignment Details	6 of the original 32 subjects who had agreed to participate in the study dropped out before any exposure to the laserlight visual cue. Therefore, data are presented only for the 26 subjects who actually participated in the study, includign exposure to this laserlight visual cue.

Arm/Group Title	1 mo Baseline Before Visual Cue	2 Month Baseline Before Visual Cue
Arm/Group Description	1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the visual cue	2 month baseline using the laserlight visual cue, followed by 1 additional month using the laserlight visual cue. This group served as an active comparator control for comparison with Group 1during the 2nd month, when group 1 did use the visual cue but group 2 continued without the visual cue.
Period Title: Overall Study
Started	16	16
Completed	14	12
Not Completed	2	4

Baseline Characteristics

Arm/Group Title		All Study Participants Who Completed Protocol
Arm/Group Description		This analysis includes all study participants who completed the protocol (n = 26)
Overall Number of Baseline Participants		26
Baseline Analysis Population Description		32 subjects initially signed the consent form, but 6 dropped out prior to any exposure to the laserlight visual cue. Therefore, data in this study are included for the 26 subjects who entered the study and were eventually exposed to the laserlight visual cue.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	10 38.5%
	>=65 years	16 61.5%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	26 participants
		71; (58 to 92)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	Female	5 19.2%
	Male	21 80.8%
		[1] Measure Description: Gender distribution: male versus female
Region of Enrollment [1]; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	26 participants
		26
		[1] Measure Description: Regions of subject enrollment

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
Description	The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.
Time Frame	2-3 months

Outcome Measure Data

Analysis Population Description

These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.

Arm/Group Title	1 Month Baseline Before Use of Laserlight Visual Cue
Arm/Group Description:	subjects had a 1 month baseline before use of laserlight visual cue
Overall Number of Participants Analyzed	13
Mean (Standard Error); Unit of Measure: change in FOGQ score
	1.25 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1 Month Baseline Before Use of Laserlight Visual Cue
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0152
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	two-tailed paired t-test
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.26 to 2.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.48
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature
Description	Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period
Time Frame	2-3 months

Outcome Measure Data

Analysis Population Description

All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue

Arm/Group Title	All Study Participants Who Completed Protocol
Arm/Group Description:	All 26 subjects who entered the study and completed the study protocol.
Overall Number of Participants Analyzed	26
Mean (Standard Deviation); Unit of Measure: seconds
Before laserlingh visual cue	65 (26.2)
With the laserlight visual cue	57.6 (23.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Study Participants Who Completed Protocol
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	50
	Confidence Interval	(2-Sided) 95%; 23.9 to 76.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 11.7
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.
Description	Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).
Time Frame	2-3 months

Outcome Measure Data

Analysis Population Description

10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue

Arm/Group Title	All Study Participants Who Completed Protocol
Arm/Group Description:	All 26 Study Participants who completed protocol. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue.
Overall Number of Participants Analyzed	10
Mean (Standard Deviation); Unit of Measure: falls per week
without laserlight visual cue	3.23 (1.31)
with laserlight visual cue	2.12 (0.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Study Participants Who Completed Protocol
	Comments	two-tailed Wilcoxan signed-rank sum test
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	two-tailed Wilcoxan signed-rank sum test
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.11
	Parameter Dispersion	Type: Standard Deviation; Value: 1.31
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage Change in Falls
Description	The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.
Time Frame	1 to 2 months

Outcome Measure Data

Analysis Population Description

10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue

Arm/Group Title	1 or 2 Month Baseline Before Use of Laserlight Visual Cue
Arm/Group Description:	subjects had a 1 month baseline before use of laserlight visual cue
Overall Number of Participants Analyzed	10
Mean (Standard Deviation); Unit of Measure: % change in fall frequency
	39.5 (9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1 or 2 Month Baseline Before Use of Laserlight Visual Cue
	Comments	The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0
	Type of Statistical Test	Other
	Comments	The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0
Statistical Test of Hypothesis	P-Value	0.002
	Comments	Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	Average of 6.5 weeks per subject
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	All Study Participants
Arm/Group Description	[Not Specified]
All-Cause Mortality
	All Study Participants
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)
Total	0/26 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	All Study Participants
	Affected / at Risk (%)
Total	0/26 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. David K. Simon, Associate Professor of Neurology
• Organization: Beth Israel Deaconess Medical Center and Harvard Medical School
• Phone: 617-735-3251
• EMail: dsimon1@bidmc.harvard.edu

Publications:

Donovan S, Lim C, Diaz N, Browner N, Rose P, Sudarsky LR, Tarsy D, Fahn S, Simon DK. Laserlight cues for gait freezing in Parkinson's disease: an open-label study. Parkinsonism Relat Disord. 2011 May;17(4):240-5. doi: 10.1016/j.parkreldis.2010.08.010. Epub 2010 Sep 3.

• Responsible Party: David K. Simon, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00320242
• Other Study ID Numbers: 2006P000085
• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Results First Submitted: December 23, 2015
• Results First Posted: July 14, 2017
• Last Update Posted: July 14, 2017