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NCT04016844 · ClinicalTrials.gov registry record · NA
tDCS and Glucose Uptake in Leg Muscles
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT04016844: Completed NA study, sponsored by University of Iowa.
NCT04016844 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04016844, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
Participants are walking on a treadmill with tDCS or SHAM, followed by a positron emission tomography (PET) scan to measure glucose uptake in leg muscles. SUV asymmetry indices (AIs) were calculated to determine the magnitude of asymmetry between the more- and less-affected legs with a previously used equation: ((less-affected side - more-affected side)/((0.5) × (less-affected side + more- affected side)) × 100). An AI value ≥ 10% was considered asymmetric.
Interventions
- DEVICE transcranial direct current stimulation or SHAM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-12-06 |
| Est. Completion | 2020-10-01 |
| Phase | NA |
What the finished NCT04016844 record still lists
NCT04016844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which transcranial direct current stimulation or SHAM is the first listed.
NCT04016844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04016844 about?
NCT04016844 is a clinical study titled "tDCS and Glucose Uptake in Leg Muscles". 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 Step...
What is the current status of trial NCT04016844?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2019-12-06. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT04016844?
The interventions under investigation include: transcranial direct current stimulation or SHAM (DEVICE).
Who is sponsoring clinical trial NCT04016844?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04016844's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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