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

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NYU Langone Health

Status

Completed

Conditions

Multiple Sclerosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03499314
17-00522

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

65 participants in 2 patient groups, including a placebo group

RS-tDCS Stimulation
Experimental group
Description:
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Treatment:
Other: Manual dexterity training
Device: Active RS-tDCS +At-Home Manual Dexterity Training
Sham Stimulation
Placebo Comparator group
Description:
20 ×20-minute sessions sham tDCS
Treatment:
Other: Manual dexterity training
Device: Sham RS-tDCS +At-Home Manual Dexterity Training

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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