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

NYU Langone Health

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: Physical Activity (PA)

Device: active tDCS

Device: sham tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT03658668

18-00534

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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
History of clinically significant abnormalities on electrocardiogram (EKG)
Presence of chronic medical illness and/or severe ataxia
Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
Alcohol or other substance use disorder
Pregnant or breastfeeding