Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis

NYU Langone Health1 site in 1 country23 target enrollmentOctober 3, 2018

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: NYU Langone Health
Enrollment: 23
Locations: 1
Primary Endpoint: Change in Gait Velocity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.

The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).

Portions of this study may be completed remotely.

Registry

clinicaltrials.gov

Start Date

October 3, 2018

End Date

June 10, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Stable and continuous access to internet service at home
•Adequate home facilities (enough space, access to quiet and distraction free area)
•Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
•Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
•Clinically stable and stable on treatment with disease modifying agents at least from 6 months
•Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
•Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
•Able to use study equipment
•Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
•Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria

•Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
•Primary psychiatric disorder that would influence ability to participate
•Receiving current treatment for epilepsy
•Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
•History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
•Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
•Treatment for a communicable skin disorder currently or over the past 12 months
•History of uncontrolled or labile hypertension
•Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
•Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score \< 85

Outcomes

Primary Outcomes

Change in Gait Velocity

Time Frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Measured by a 10 meter walk test using wearable inertial sensors

Change in Stride Length

Time Frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Measured by a 10 meter walk test using wearable inertial sensors

Secondary Outcomes

Change 21-item Modified Fatigue Impact Scale Score(Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks))
Percent of tDCS Sessions Completed(End of Final Treatment Session (Up to Week 3))
Change in 12-item Multiple Sclerosis Walking Scale Score(Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks))