Combined Effect of Transcranial Direct Current Stimulation (tDCS) and
Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- active tDCS
Placebo
- sham tDCS
Given to everyone in the trial
- Physical Activity (PA)
Results by group
Change in Gait Velocity
Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Active tDCS+PA | 0.33 meters/second (m/s) | 0.32 (Standard Deviation) | 9 |
| Sham tDCS+PA | 0.01 meters/second (m/s) | 0.33 (Standard Deviation) | 6 |
Active tDCS+PA
Sham tDCS+PA
Change in Stride Length
Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Active tDCS+PA | 0.32 meters (m) | 0.17 (Standard Deviation) | 9 |
| Sham tDCS+PA | -0.02 meters (m) | 0.2 (Standard Deviation) | 6 |
Active tDCS+PA
Sham tDCS+PA
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Active tDCS+PA | 13 | 0 (0.0%) | 0 |
| Sham tDCS+PA | 9 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Gait Velocity
Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Walking and mobilityChange in Stride Length
Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Walking and mobility
Other measures (3)
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)
Walking and mobilityChange 21-item Modified Fatigue Impact Scale Score
Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Fatigue
Who could take part
Relapsing MS · 18 to 70 · EDSS 1 to 6.5
Show the full 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 * 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Walking in multiple sclerosis improves with tDCS: a randomized, double-blind, sham-controlled study.Ann Clin Transl Neurol · 2020
Results
Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.
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History
Started
Oct 2018
Main results due
Jun 2021
Finished
Jun 2021
Results posted
Aug 2023