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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Active RS-tDCS +At-Home Manual Dexterity Training; Device: Sham RS-tDCS +At-Home Manual Dexterity Training; Other: Manual dexterity training

• Registration Number: NCT03499314
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-09
• Study Start: 2018-04-15
• Study First Posted: 2018-04-17
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Results First Submitted: 2021-12-22
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Results First Posted: 2022-03-09
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Manual dexterity training	20 ×20-minute sessions sham tDCS
RS-tDCS Stimulation	Manual dexterity training	20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
RS-tDCS Stimulation	Active RS-tDCS +At-Home Manual Dexterity Training	20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Sham Stimulation	Sham RS-tDCS +At-Home Manual Dexterity Training	20 ×20-minute sessions sham tDCS

Primary Outcome Measures

Name	Time	Method
Mean Preload Phase Duration (PLD)	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States