tDCS and Glucose Uptake in Leg Muscles
Transcranial Direct Current Stimulation to Reduce Asymmetric Glucose Uptake in Leg Muscles of Persons 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
Placebo
- transcranial direct current stimulation or SHAM
Results by group
Glucose Uptake in Leg Muscles
Six Months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| tDCS Effects on Glucose Uptake in Leg Muscles | 6.3 Percentage (%) | 6.2 (Standard Deviation) | 4 |
| SHAM Effects on Glucose Uptake in Leg Muscles | 16.4 Percentage (%) | 13.6 (Standard Deviation) | 4 |
tDCS Effects on Glucose Uptake in Leg Muscles
SHAM Effects on Glucose Uptake in Leg Muscles
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| tDCS/SHAM Effects on Glucose Uptake in Leg Muscles | 4 | 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
Glucose Uptake in Leg Muscles
Six Months
Walking and mobility
Other measures (1)
Ratings of Perceived Exertion (RPE)
Six Months
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 (MS) * 18-70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6) * Self-reported differences in function between legs, able to walk for 20 min.
Exclusion criteria
* MS relapse within last 60 days * inability to fast for 6 hours * hyperglycemia (fasting blood sugar > 200 mg/dL) * insulin-dependent diabetes * 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, pregnant, history of seizure disorders (or on medications known to lower seizure threshold) * hydrocephalus.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study is to examine the efficacy of tDCS to improving walking in people with Multiple Sclerosis (PwMS). Our study compromises 1 group of subjects with MS which will attend the lab for three sessions. In the first session, subjects will be consented, complete the Patient Determined Disease Steps (PDDS), the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. The second and third sessions will involve whole-body FDG PET imaging. During each of these sessions, the subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS or SHAM, in a blinded manner, will be applied to the motor cortex (M1) corresponding to the more-affected leg. Approximately 2 minutes into the walking, [18F]fluorodeoxyglucose (FDG) will be administered by IV injection. Immediately after the walking is completed, the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired for the evaluation of glucose metabolism in the brain, spine, and lower extremities. The third session will be identical to the second session with the exception that the opposite condition (tDCS or SHAM) will be used.
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History
Started
Dec 2019
Main results due
Oct 2020
Finished
Oct 2020
Results posted
Jan 2023