Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

65

Study ID:

NCT03499314

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

65

Study ID:

NCT03499314

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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