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



Status:Recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:10/6/2018
Start Date:October 3, 2018
End Date:October 2019
Contact:Claire Choi
Email:claire.choi@nyumc.org
Phone:929 455 5141

Use our guide to learn which trials are right for you!

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)


Inclusion Criteria:

- 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 5 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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Leigh Charvet, MD
Phone: 929-455-5141
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials