A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Active RS-tDCS +At-Home Manual Dexterity Training
* Device: Sham RS-tDCS +At-Home Manual Dexterity Training
* Other: Manual dexterity training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RS-tDCS Stimulation<br>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<br>* Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes<br>Other: Manual dexterity training<br>* 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.<br>|
| Placebo Comparator: Sham Stimulation<br>20 ×20-minute sessions sham tDCS | Device: Sham RS-tDCS +At-Home Manual Dexterity Training<br>* Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds<br>Other: Manual dexterity training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 30 minutes for each of 20 sessions, values averaged across sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anodal transcranial stimulation (tDCS)