N/A
N=65
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03499314 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Mean Preload Phase Duration (PLD) — 0.152; 0.238; 0.163; 0.202 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active RS-tDCS +At-Home Manual Dexterity Training (Device); Sham RS-tDCS +At-Home Manual Dexterity Training (Device); Manual dexterity training (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Preload Phase Duration (PLD) |
0.152; 0.238; 0.163; 0.202 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03499314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.