Trial Outcomes & Findings for A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS) (NCT NCT03499314)
NCT ID: NCT03499314
Last Updated: 2022-03-09
Results Overview
(PLD) is the duration of finger contact until the onset of positive load force. It assesses the time taken to stabilize grasp and is a robust measure of grasp execution.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
baseline and 30 minutes for each of 20 sessions, values averaged across sessions
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
Sham Stimulation
20 ×20-minute sessions sham tDCS
Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
Sham Stimulation
20 ×20-minute sessions sham tDCS
Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
|---|---|---|
|
Overall Study
Time Commitment
|
1
|
2
|
|
Overall Study
Medical issue unrelated to research study
|
1
|
1
|
Baseline Characteristics
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
RS-tDCS Stimulation
n=33 Participants
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
Sham Stimulation
n=32 Participants
20 ×20-minute sessions sham tDCS
Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.23 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
53.72 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
54.49 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 30 minutes for each of 20 sessions, values averaged across sessions(PLD) is the duration of finger contact until the onset of positive load force. It assesses the time taken to stabilize grasp and is a robust measure of grasp execution.
Outcome measures
| Measure |
RS-tDCS Stimulation
n=30 Participants
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
Sham Stimulation
n=24 Participants
20 ×20-minute sessions sham tDCS
Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
|---|---|---|
|
Mean Preload Phase Duration (PLD)
Post-Stimulation
|
0.163 seconds
Standard Deviation 0.0426
|
0.202 seconds
Standard Deviation 0.0476
|
|
Mean Preload Phase Duration (PLD)
Pre-Stimulation
|
0.152 seconds
Standard Deviation 0.0424
|
0.238 seconds
Standard Deviation 0.0481
|
Adverse Events
RS-tDCS Stimulation
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RS-tDCS Stimulation
n=33 participants at risk
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Active RS-tDCS +At-Home Manual Dexterity Training: Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
Sham Stimulation
n=32 participants at risk
20 ×20-minute sessions sham tDCS
Sham RS-tDCS +At-Home Manual Dexterity Training: Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Manual dexterity training: Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
|
|---|---|---|
|
General disorders
Skin Tingling
|
51.5%
17/33 • 1 month
|
62.5%
20/32 • 1 month
|
|
General disorders
Skin Itching
|
48.5%
16/33 • 1 month
|
31.2%
10/32 • 1 month
|
|
General disorders
Skin Warming
|
48.5%
16/33 • 1 month
|
21.9%
7/32 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place