Transcranial Direct Current Stimulation and Walking in Multiple Sclero
Can Transcranial Direct Stimulation Improve Walking in 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
- tDCS
Placebo
- SHAM
Results by group
Distance Walked on a Treadmill With tDCS
one week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Before Walking | 375 m | 78 (Standard Deviation) | 6 |
| During Walking | 285 m | 131 (Standard Deviation) | 6 |
Before Walking
During Walking
Distance Walked on a Treadmill With SHAM
one week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Before Walking | 366 m | 90 (Standard Deviation) | 6 |
| During Walking | 298 m | 133 (Standard Deviation) | 6 |
Before Walking
During Walking
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Before Walking Active/SHAM | 6 | 0 (0.0%) | 0 |
| During Walking Active/SHAM | 6 | 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
Distance Walked on a Treadmill With tDCS
one week
Walking and mobilityDistance Walked on a Treadmill With SHAM
one week
Walking and mobility
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
* medically diagnosed with Multiple Sclerosis, * moderate disability (Patient Determined Disease Steps (PDDS) core 2-6), -self-- reported differences in function between legs, able to walk for 6min. -
Exclusion criteria
* relapse within last 60 days, * high risk for cardiovascular disease (ACSM risk classification), * changes in disease modifying medications within last 45 days, * concurrent neurological/neuromuscular disease, * hospitalization within last 90 days, * diagnosed depression, inability to understand/sign informed consent.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Weakness on one side of the body is a hallmark of Multiple Sclerosis (MS), which has been determined to be a significant cause of progressive worsening of walking abilities. Currently, there are no efficient rehabilitation strategies available to target strength asymmetries and walking impairments. Many of the current treatments, including pharmaceuticals, are only mildly effective and are often very expensive. Thus, the development of practical, inexpensive, and effective adjunct treatments is needed. The study is to examine the efficacy of different tDCS protocols at improving walking in PwMS. Although the details of the studies slightly vary, the global aspects of the experimental procedures are identical with the exception that the tDCS stimulation parameter timing differs between the groups. The study will be double-blind, sham-controlled, randomized cross-over design. Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg. The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and a 6 minute walk test (6-MWT) for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURINGtDCS, DURINGSHAM. Group 2: BEFOREtDCS, BEFORESHAM. The conditions in each group will be in a randomized order. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham, which results in after effects lasting through the completion of the 6 MWT. tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg either before or during the 6 min walk test
Papers
Loading reviews and guidelines…
History
Started
Feb 2019
Main results due
Jul 2019
Finished
Jul 2019
Results posted
Dec 2022