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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499314
• Other study ID #: 17-00522
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

Device:
• Active RS-tDCS +At-Home Manual Dexterity Training
Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
• Sham RS-tDCS +At-Home Manual Dexterity Training
Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds

Other:
• Manual dexterity training
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 30 minutes for each of 20 sessions, values averaged across sessions