Trial Outcomes & Findings for Transcranial Direct Current Stimulation and Walking in Multiple Sclerosis (NCT NCT03757819)
NCT ID: NCT03757819
Last Updated: 2022-12-21
Results Overview
6 min walk test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
one week
Results posted on
2022-12-21
Participant Flow
Participant milestones
| Measure |
BEFORE Walking, SHAM First Then tDCS
In the BEFORE walking group, received SHAM in session two and tDCS in session three.
|
BEFORE Walking, tDCS First Then SHAM
In the BEFORE walking group, received tDCS in session two and then SHAM in session three.
|
DURING Walking, SHAM First Then tDCS
In the DURING walking group, received SHAM in session two and then tDCS in session three.
|
DURING Walking, tDCS First Then SHAM
In the DURING walking group, received tDCS in session two and then SHAM in session three.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation and Walking in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Before Walking tDCS/SHAM
n=6 Participants
To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention.
tDCS: Brain Stimulation
To investigate the effects of SHAM applied before walking versus during to evaluate effectiveness of the intervention.
SHAM: Placebo device
|
During Walking tDCS/SHAM
n=6 Participants
To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention.
tDCS: Brain Stimulation
To investigate the effects of SHAM applied before walking versus during to evaluate effectiveness of the intervention.
SHAM: Placebo device
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 14 • n=5 Participants
|
56 years
STANDARD_DEVIATION 7 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one week6 min walk test
Outcome measures
| Measure |
Before Walking
n=6 Participants
To investigate the effects of tDCS applied before walking to evaluate effectiveness of the intervention.
tDCS: Brain Stimulation
SHAM: Placebo device
|
During Walking
n=6 Participants
To investigate the effects of tDCS applied during to evaluate effectiveness of the intervention.
tDCS: Brain Stimulation
SHAM: Placebo device
|
|---|---|---|
|
Distance Walked on a Treadmill With tDCS
|
375 m
Standard Deviation 78
|
285 m
Standard Deviation 131
|
PRIMARY outcome
Timeframe: one week6 min walk test
Outcome measures
| Measure |
Before Walking
n=6 Participants
To investigate the effects of tDCS applied before walking to evaluate effectiveness of the intervention.
tDCS: Brain Stimulation
SHAM: Placebo device
|
During Walking
n=6 Participants
To investigate the effects of tDCS applied during to evaluate effectiveness of the intervention.
tDCS: Brain Stimulation
SHAM: Placebo device
|
|---|---|---|
|
Distance Walked on a Treadmill With SHAM
|
366 m
Standard Deviation 90
|
298 m
Standard Deviation 133
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one weekLeg extensor strength and Leg flexor strength data were obtained but have not been used for data analysis.
Outcome measures
Outcome data not reported
Adverse Events
Before Walking Active/SHAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
During Walking Active/SHAM
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