Skip to main content
OpenTrials
Completed

NCT Number: NCT03658668

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.

Other names: Soterix 1x1 tDCS mini-CT

Sham tDCS

Device

During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.

Physical Activity (PA)

Other

20 minutes of cycling on an ergonomic cross-trainer

Primary outcomes

  1. 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

  2. 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

  1. Percent of tDCS Sessions Completed

    Time frame: End of Final Treatment Session (Up to Week 3)

  2. Change in 12-item Multiple Sclerosis Walking Scale Score

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

    12-item questionnaire assessing how multiple sclerosis (MS) affects walking abilities. Items are ranked on a scale from 1 (not at all) to 5 (extremely). The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater impact of MS on walking abilities.

  3. Change 21-item Modified Fatigue Impact Scale Score

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

    21-item questionnaire assessing how fatigue may affect a person. Items are ranked on a scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0 to 84; scores indicate greater impact of fatigue.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2018
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.