Trial Outcomes & Findings for Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia (NCT NCT03120013)
NCT ID: NCT03120013
Last Updated: 2020-03-03
Results Overview
International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline - 2 weeks
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
Real tDCS, Then Sham tDCS
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.
|
Sham tDCS, Then Real tDCS
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.
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
10
|
11
|
|
First Intervention (2 Weeks)
Received Intervention
|
10
|
11
|
|
First Intervention (2 Weeks)
COMPLETED
|
10
|
10
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (6 Months)
STARTED
|
10
|
10
|
|
Washout (6 Months)
COMPLETED
|
10
|
10
|
|
Washout (6 Months)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
10
|
10
|
|
Second Intervention (2 Weeks)
COMPLETED
|
10
|
10
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Real tDCS, Then Sham tDCS
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.
|
Sham tDCS, Then Real tDCS
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.
|
|---|---|---|
|
First Intervention (2 Weeks)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Participants who were randomized to receive either real tDCS or sham tDCS
|
|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
|
Scale for the Assessment and Rating of Ataxia (SARA) score
|
20.2 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
International Cooperative Ataxia Rating Scale (ICARS) score
|
53.0 units on a scale
STANDARD_DEVIATION 18.6 • n=5 Participants
|
|
9 Hole Peg Test (Dominant hand)
|
53.0 seconds
STANDARD_DEVIATION 24.3 • n=5 Participants
|
|
9 Hole Peg Test (non-Dominant hand)
|
56.1 seconds
STANDARD_DEVIATION 21.5 • n=5 Participants
|
|
8 Meter Walking Time
|
9.4 seconds
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Short-Form Health Survey 36
|
54.7 units on a scale
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Cerebellar Brain Inhibition
|
0.94 milli volt
STANDARD_DEVIATION 0.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - 2 weeksInternational Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Baseline
|
53.0 units on a scale
Standard Deviation 18.6
|
52.7 units on a scale
Standard Deviation 19.4
|
|
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
2 Weeks
|
43.0 units on a scale
Standard Deviation 19.6
|
52.1 units on a scale
Standard Deviation 19.7
|
PRIMARY outcome
Timeframe: Baseline - 2 weeksScale 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).
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
|
15.8 units on a scale
Standard Deviation 7.6
|
19.7 units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline - 2 weeks - 1 month - 3 monthsInternational Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
Baseline
|
53.0 units on a scale
Standard Deviation 18.6
|
52.7 units on a scale
Standard Deviation 19.4
|
|
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
2 Weeks
|
43.0 units on a scale
Standard Deviation 19.6
|
52.1 units on a scale
Standard Deviation 19.7
|
|
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
1 Month
|
41.3 units on a scale
Standard Deviation 19.6
|
52.5 units on a scale
Standard Deviation 19.2
|
|
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
3 Months
|
44.2 units on a scale
Standard Deviation 19.6
|
52.4 units on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Baseline - 2 weeks - 1 month - 3 monthsScale 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).
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
Baseline
|
20.2 units on a scale
Standard Deviation 7.3
|
19.9 units on a scale
Standard Deviation 7.3
|
|
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
2 Weeks
|
15.8 units on a scale
Standard Deviation 7.6
|
19.7 units on a scale
Standard Deviation 7.5
|
|
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
1 Month
|
15.1 units on a scale
Standard Deviation 7.7
|
19.7 units on a scale
Standard Deviation 7.3
|
|
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
3 Months
|
16.1 units on a scale
Standard Deviation 7.9
|
19.9 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline - 2 weeks - 1 month - 3 months4 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.
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the 9 Hole Peg Test (9HPT) Score From Baseline
Baseline
|
53.0 seconds
Standard Deviation 24.3
|
52.2 seconds
Standard Deviation 25.9
|
|
Change in the 9 Hole Peg Test (9HPT) Score From Baseline
2 Weeks
|
46.2 seconds
Standard Deviation 21.3
|
53.4 seconds
Standard Deviation 23.8
|
|
Change in the 9 Hole Peg Test (9HPT) Score From Baseline
1 Month
|
47.1 seconds
Standard Deviation 21.9
|
55.8 seconds
Standard Deviation 28.1
|
|
Change in the 9 Hole Peg Test (9HPT) Score From Baseline
3 Months
|
49.5 seconds
Standard Deviation 20.5
|
54.2 seconds
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: Baseline - 2 weeks - 1 month - 3 months4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment.
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the 8-Meter Walking Time (8MW) Score From Baseline
Baseline
|
9.4 seconds
Standard Deviation 3.4
|
9.3 seconds
Standard Deviation 3.3
|
|
Change in the 8-Meter Walking Time (8MW) Score From Baseline
2 Weeks
|
8.0 seconds
Standard Deviation 2.7
|
9.0 seconds
Standard Deviation 3.9
|
|
Change in the 8-Meter Walking Time (8MW) Score From Baseline
1 Month
|
7.8 seconds
Standard Deviation 2.7
|
9.9 seconds
Standard Deviation 5.0
|
|
Change in the 8-Meter Walking Time (8MW) Score From Baseline
3 Months
|
8.4 seconds
Standard Deviation 2.8
|
9.7 seconds
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline - 2 weeks - 1 month - 3 monthsCerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.
Outcome measures
| Measure |
Real tDCS
n=18 Participants
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)
|
Sham tDCS
n=18 Participants
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)
|
|---|---|---|
|
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
Baseline
|
0.94 millivolts
Standard Deviation 0.12
|
0.88 millivolts
Standard Deviation 0.12
|
|
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
2 Weeks
|
0.54 millivolts
Standard Deviation 0.13
|
0.91 millivolts
Standard Deviation 0.12
|
|
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
1 Month
|
0.65 millivolts
Standard Deviation 0.14
|
0.95 millivolts
Standard Deviation 0.13
|
|
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
3 Months
|
0.74 millivolts
Standard Deviation 0.11
|
0.90 millivolts
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline - 2 weeks - 1 month - 3 monthsThe 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).
Outcome measures
| Measure |
Real tDCS
n=20 Participants
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)
|
Sham tDCS
n=20 Participants
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)
|
|---|---|---|
|
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
Baseline
|
54.7 units on a scale
Standard Deviation 17.5
|
55.3 units on a scale
Standard Deviation 19.5
|
|
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
2 Weeks
|
66.5 units on a scale
Standard Deviation 17.5
|
57.9 units on a scale
Standard Deviation 18.5
|
|
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
1 Month
|
66.7 units on a scale
Standard Deviation 16.8
|
60.1 units on a scale
Standard Deviation 17.8
|
|
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline
3 Months
|
61.1 units on a scale
Standard Deviation 18.8
|
56.3 units on a scale
Standard Deviation 18.8
|
Adverse Events
Real tDCS, Then Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS, Then Real tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place