A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Mean Preload Phase Duration (PLD)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Definite MS diagnosis, progressive subtype
- •9HPT score between -1.0 and -4.0 standard deviations from age-based normative data
- •Score of < 7.5 or less on the EDSS (with caregiver proxy required for those with scores of 6.5 or greater)*
- •Ability to understand the informed consent process and provide consent to participate in the study
Exclusion Criteria
- •Primary neurologic, psychiatric or other medical disorder other than MS
- •Use of upper extremity Botox injection within 3 months
- •Current use of intrathecal Baclofen
- •History of seizure disorder
- •History of head trauma or medical device in head or neck
- •Clinically significant abnormality on EKG
- •Symbol Digit Modalities Test or SDMT score ≥3.0 SD from published norms
- •WRAT-4 reading level below average (<85) (estimated general intellectual function)
- •Skin disorder/sensitive near stimulation locations
Arms & Interventions
RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Intervention: Active RS-tDCS +At-Home Manual Dexterity Training (Device)
RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Intervention: Manual dexterity training (Other)
Sham Stimulation
20 ×20-minute sessions sham tDCS
Intervention: Sham RS-tDCS +At-Home Manual Dexterity Training (Device)
Sham Stimulation
20 ×20-minute sessions sham tDCS
Intervention: Manual dexterity training (Other)
Outcomes
Primary Outcomes
Mean Preload Phase Duration (PLD)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported