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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Active RS-tDCS +At-Home Manual Dexterity Training; Other: Manual dexterity training; Device: Sham RS-tDCS +At-Home Manual Dexterity Training

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2018
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (ACTUAL): April 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Anodal transcranial stimulation (tDCS)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
• Other Study ID Numbers: 17-00522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes