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Trial record 86 of 90 for:    "Brain Diseases" AND "Multiple System Atrophy"

Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia (CStDCSAtaxia)

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: NCT03120013
Recruitment Status : Completed
First Posted : April 19, 2017
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Ataxia, Cerebellar
Cerebellar Ataxia
Spinocerebellar Ataxias
Ataxia, Spinocerebellar
Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia 3
Spinocerebellar Degenerations
Friedreich Ataxia
Ataxia With Oculomotor Apraxia
Multiple System Atrophy
Interventions Device: Anodal cerebellar and cathodal spinal tDCS
Device: Sham cerebellar and sham spinal tDCS
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Real tDCS, Then Sham tDCS Sham tDCS, Then Real tDCS
Hide Arm/Group Description Participants first received real tDCS (anodal cerebellar and cathodal spinal tDCS) 5 days/week for 2 weeks. After a washout period of 6 months, they then received sham tDCS (sham cerebellar and sham spinal tDCS) 5 days/week for 2 weeks. Participants first received sham tDCS (sham cerebellar and sham spinal tDCS) 5 days/week for 2 weeks. After a washout period of 6 months, they then received real tDCS (anodal cerebellar and cathodal spinal tDCS) 5 days/week for 2 weeks.
Period Title: First Intervention (2 Weeks)
Started 10 11
Received Intervention 10 11
Completed 10 10
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Washout (6 Months)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Intervention (2 Weeks)
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Participants who were randomized to receive either real tDCS or sham tDCS
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Baseline analysis are reported for 20 participants who completed the first intervention
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
54.6  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 20 participants
20
Scale for the Assessment and Rating of Ataxia (SARA) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
20.2  (7.4)
[1]
Measure Description: Scale for the Assessment and Rating of Ataxia (SARA): clinical scale that is based on a semi-quantitative assessment of cerebellar ataxia on an impairment level. It consists of an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
International Cooperative Ataxia Rating Scale (ICARS) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
53.0  (18.6)
[1]
Measure Description: International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale consisting of 19 items divided into 4 weighted subscores including posture and gait disturbances, limb kinetic function, speech disorder, and oculomotor deficits, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
9 Hole Peg Test (Dominant hand)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 20 participants
53.0  (24.3)
[1]
Measure Description: 4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The 9HPT is a commonly used test to assess finger dexterity: the patient picks the pegs 1 at time and puts them in 9 holes on a peg board until all holes are filled and then removes them 1 at a time as quickly as possible. The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment.
9 Hole Peg Test (non-Dominant hand)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 20 participants
56.1  (21.5)
[1]
Measure Description: 4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The 9HPT is a commonly used test to assess finger dexterity: the patient picks the pegs 1 at time and puts them in 9 holes on a peg board until all holes are filled and then removes them 1 at a time as quickly as possible. The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment.
8 Meter Walking Time   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 20 participants
9.4  (3.4)
[1]
Measure Description: 4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). The 8MW is defined as the time needed to walk 8 m as quickly as possible but safely with any device but without the help of another person or wall. Longer times represent greater impairment.
Short-Form Health Survey 36   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
54.7  (17.5)
[1]
Measure Description: The Italian version of the Short-Form Health Survey 36 (SF-36), an interview-administered self-reported scale consisting of 36 scaled scores assessing 8 subdomains (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health, communication, psychosocial and energy), was used to assess changes in the patient’s quality of life. The scale ranges from 0 (more disability) to 100 (less disability).
Cerebellar Brain Inhibition   [1] 
Mean (Standard Deviation)
Unit of measure:  Milli volt
Number Analyzed 20 participants
0.94  (0.12)
[1]
Measure Description: Cerebellar brain inhibition (CBI) is evaluated with a transcranial magnetic stimulation (TMS) protocol, using two coils. One placed over the cerebellar hemisphere and the other positioned on the contralateral primary motor cortex, with motor evoked potentials (MEPs) recorded on the first dorsal interosseous muscle. CBI measures the inhibition exerted by cerebellar structures on the motor cortex, and thus on MEPs amplitude, reflecting the integrity of the cerebellar-thalamo-cortical pathway. Lower values reflect higher inhibition and thus reduced impairment.
1.Primary Outcome
Title Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Hide Description International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Time Frame Baseline - 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 53.0  (18.6) 52.7  (19.4)
2 Weeks 43.0  (19.6) 52.1  (19.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
Hide Description Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
Time Frame Baseline - 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.8  (7.6) 19.7  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Hide Description International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Time Frame Baseline - 2 weeks - 1 month - 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 53.0  (18.6) 52.7  (19.4)
2 Weeks 43.0  (19.6) 52.1  (19.7)
1 Month 41.3  (19.6) 52.5  (19.2)
3 Months 44.2  (19.6) 52.4  (19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
Hide Description Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
Time Frame Baseline - 2 weeks - 1 month - 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20.2  (7.3) 19.9  (7.3)
2 Weeks 15.8  (7.6) 19.7  (7.5)
1 Month 15.1  (7.7) 19.7  (7.3)
3 Months 16.1  (7.9) 19.9  (7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in the 9 Hole Peg Test (9HPT) Score From Baseline
Hide Description 4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment.
Time Frame Baseline - 2 weeks - 1 month - 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 53.0  (24.3) 52.2  (25.9)
2 Weeks 46.2  (21.3) 53.4  (23.8)
1 Month 47.1  (21.9) 55.8  (28.1)
3 Months 49.5  (20.5) 54.2  (26.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in the 8-Meter Walking Time (8MW) Score From Baseline
Hide Description 4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment.
Time Frame Baseline - 2 weeks - 1 month - 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 9.4  (3.4) 9.3  (3.3)
2 Weeks 8.0  (2.7) 9.0  (3.9)
1 Month 7.8  (2.7) 9.9  (5.0)
3 Months 8.4  (2.8) 9.7  (4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
Hide Description Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.
Time Frame Baseline - 2 weeks - 1 month - 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: millivolts
Baseline 0.94  (0.12) 0.88  (0.12)
2 Weeks 0.54  (0.13) 0.91  (0.12)
1 Month 0.65  (0.14) 0.95  (0.13)
3 Months 0.74  (0.11) 0.90  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
Hide Description The Italian version of the Short-Form Health Survey 36 (SF-36): consists of 36 scaled score, yielding a total score of 0 (more disability) to 100 (less disability).
Time Frame Baseline - 2 weeks - 1 month - 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real tDCS Sham tDCS
Hide Arm/Group Description:

10 days anodal cerebellar and cathodal spinal tDCS

Anodal cerebellar and cathodal spinal tDCS: 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

10 days sham cerebellar and sham spinal tDCS

Sham cerebellar and sham spinal tDCS: 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 54.7  (17.5) 55.3  (19.5)
2 Weeks 66.5  (17.5) 57.9  (18.5)
1 Month 66.7  (16.8) 60.1  (17.8)
3 Months 61.1  (18.8) 56.3  (18.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.043
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 9 months
Adverse Event Reporting Description Adverse event has been defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research.
 
Arm/Group Title Real tDCS, Then Sham tDCS Sham tDCS, Then Real tDCS
Hide Arm/Group Description Participants who were randomized to receive real tDCS first and then sham tDCS Participants who were randomized to receive sham tDCS first and then real tDCS
All-Cause Mortality
Real tDCS, Then Sham tDCS Sham tDCS, Then Real tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Real tDCS, Then Sham tDCS Sham tDCS, Then Real tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Real tDCS, Then Sham tDCS Sham tDCS, Then Real tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
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: Prof. Barbara Borroni
Organization: University of Brescia
Phone: +39 0303995631
Other Publications:
Responsible Party: Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03120013     History of Changes
Other Study ID Numbers: NP1576
First Submitted: April 14, 2017
First Posted: April 19, 2017
Results First Submitted: May 23, 2018
Results First Posted: June 28, 2019
Last Update Posted: June 28, 2019