Back to resultsA Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active RS-tDCS +At-Home Manual Dexterity Training
Sham RS-tDCS +At-Home Manual Dexterity Training
Manual dexterity training
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Anodal transcranial stimulation (tDCS)
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RS-tDCS Stimulation
Sham Stimulation
Arm Description
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
20 ×20-minute sessions sham tDCS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499314
Brief Title
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Official Title
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Anodal transcranial stimulation (tDCS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RS-tDCS Stimulation
Arm Type
Experimental
Arm Description
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
Arm Title
Sham Stimulation
Arm Type
Placebo Comparator
Arm Description
20 ×20-minute sessions sham tDCS
Intervention Type
Device
Intervention Name(s)
Active RS-tDCS +At-Home Manual Dexterity Training
Intervention Description
Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
Intervention Type
Device
Intervention Name(s)
Sham RS-tDCS +At-Home Manual Dexterity Training
Intervention Description
Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds
Intervention Type
Other
Intervention Name(s)
Manual dexterity training
Intervention Description
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 Outcome Measure Information:
Title
Mean Preload Phase Duration (PLD)
Description
(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.
Time Frame
baseline and 30 minutes for each of 20 sessions, values averaged across sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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