CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
transcranial direct current stimulation or SHAMdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04016844
NCT04016844N/ACompleted

Transcranial Direct Current Stimulation to Reduce Asymmetric Glucose Uptake in Leg Muscles of Persons With Multiple Sclerosis

University of Iowa·interventional·Posted Jul 12, 2019·Updated Jan 25, 2023

In Brief

A clinical study evaluating transcranial direct current stimulation or SHAM for Multiple Sclerosis. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 12, 2019
Enrollment StartDec 6, 2019
Primary CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.0 years ago

Interventions

transcranial direct current stimulation or SHAMdevice

A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used.