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

NCT03499314 | Completed Results FDA Device

• 1 other identifier: 17-00522
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Anodal transcranial stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RS-tDCS Stimulation

EXPERIMENTAL

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; Other: Manual dexterity training

Sham Stimulation

PLACEBO COMPARATOR

20 ×20-minute sessions sham tDCS

Device: Sham RS-tDCS +At-Home Manual Dexterity Training; Other: Manual dexterity training

Interventions

Active RS-tDCS +At-Home Manual Dexterity Training DEVICE

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

RS-tDCS Stimulation

Sham RS-tDCS +At-Home Manual Dexterity Training DEVICE

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

Sham Stimulation

Manual dexterity training 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.

RS-tDCS Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite MS diagnosis, progressive subtype
• HPT 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Leigh Charvet, PhD
• Organization: NYU Langone Health

Leigh.Charvet@nyulangone.org

(929) 455-5141

Study Officials

• Leigh Charvet, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: April 15, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-02

Locations

US (1)