An interventional study of Active RS-tDCS +At-Home Manual Dexterity Training and Sham RS-tDCS +At-Home Manual Dexterity Training in Multiple Sclerosis, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to rehabilitate fine motor function in individuals living with progressive multiple sclerosis (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity training. Treatment will be delivered to individuals at home using a state-of-the-art remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study visit participation. Improvements in fine motor skill will be assessed at each remote session using a novel portable grip device that measures execution and adaptation or learning of fingertip forces during grasp, which is more sensitive than standard measures of hand function.
Exclusion Criteria:
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Device: Active RS-tDCS +At-Home Manual Dexterity Training · Other: Manual dexterity training
20 ×20-minute sessions sham tDCS
Device: Sham RS-tDCS +At-Home Manual Dexterity Training · Other: Manual dexterity training
Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
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)
(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.
Time frame: baseline and 30 minutes for each of 20 sessions, values averaged across sessions
| Milestone | RS-tDCS Stimulation | Sham Stimulation |
|---|---|---|
| Started | 33 | 32 |
| Completed | 31 | 29 |
| Not completed | 2 | 3 |
| Withdrew: Time commitment | 1 | 2 |
| Withdrew: Medical issue unrelated to research study | 1 | 1 |
(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.
| seconds | RS-tDCS Stimulation | Sham Stimulation |
|---|---|---|
| Pre-Stimulation | 0.152 ± 0.0424 | 0.238 ± 0.0481 |
| Post-Stimulation | 0.163 ± 0.0426 | 0.202 ± 0.0476 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RS-tDCS Stimulation | 0/33 (0%) | 0/33 (0%) | 24/33 (72.7%) |
| Sham Stimulation | 0/32 (0%) | 0/32 (0%) | 22/32 (68.8%) |
| Event | RS-tDCS Stimulation | Sham Stimulation |
|---|---|---|
| Skin TinglingGeneral disorders | 17/33 | 20/32 |
| Skin ItchingGeneral disorders | 16/33 | 10/32 |
| Skin WarmingGeneral disorders | 16/33 | 7/32 |
| Age, Continuous(years) | RS-tDCS Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Mean | 55.23 ± 8.58 | 53.72 ± 7.62 | 54.49 ± 8.11 |
| Sex: Female, Male(Participants) | RS-tDCS Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Female | 22 | 24 | 46 |
| Male | 11 | 8 | 19 |
| Ethnicity (NIH/OMB)(Participants) | RS-tDCS Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 33 | 32 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | RS-tDCS Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| 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 | 3 | 4 | 7 |
| White | 28 | 28 | 56 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | RS-tDCS Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| United States | 33 | 32 | 65 |
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