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

NCT ID: NCT03499314

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2020-11-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RS-tDCS Stimulation

20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee

Group Type: EXPERIMENTAL

Active RS-tDCS +At-Home Manual Dexterity Training

Intervention Type: DEVICE

Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes

Manual dexterity training

Intervention Type: OTHER

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.

Sham Stimulation

20 ×20-minute sessions sham tDCS

Group Type: PLACEBO_COMPARATOR

Sham RS-tDCS +At-Home Manual Dexterity Training

Intervention Type: DEVICE

Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds

Manual dexterity training

Intervention Type: OTHER

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.

Interventions

Active RS-tDCS +At-Home Manual Dexterity Training

Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes

Intervention Type: DEVICE

Sham RS-tDCS +At-Home Manual Dexterity Training

Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Charvet, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-00522

Identifier Type: -

Identifier Source: org_study_id