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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active RS-tDCS +At-Home Manual Dexterity Training

Device

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

Sham RS-tDCS +At-Home Manual Dexterity Training

Device

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

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.

Primary outcomes

Mean Preload Phase Duration (PLD)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Apr 17, 2018
Registry last updated: Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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