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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: active tDCS
* Device: sham tDCS
* Other: Physical Activity (PA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS+PA<br> | Device: active tDCS<br>* tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.<br>* Other names: Soterix 1x1 tDCS mini-CT;Other: Physical Activity (PA)<br>* 20 minutes of cycling on an ergonomic cross-trainer<br>|
| Sham Comparator: sham tDCS+PA<br> | Device: sham tDCS<br>* 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.<br>Other: Physical Activity (PA)<br>* 20 minutes of cycling on an ergonomic cross-trainer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gait Velocity | Measured by a 10 meter walk test using wearable inertial sensors | Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks) | 
| Change in Stride Length | Measured by a 10 meter walk test using wearable inertial sensors | Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks) | 

Secondary Outcome Measures

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