N/A
Completed N=4
tDCS and Glucose Uptake in Leg Muscles
Source: ClinicalTrials.gov NCT04016844 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Glucose Uptake in Leg Muscles — 6.3; 16.4 Percentage (%)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Uptake in Leg Muscles |
6.3; 16.4 | — |
| SECONDARY Ratings of Perceived Exertion (RPE) |
6; 6 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04016844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.