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NCT04321304 · ClinicalTrials.gov registry record · NA
Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT04321304 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 35 participants.
The verdict
NCT04321304, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Although many tDCS devices are capable of a range of stimulation intensities (e.g., 0 mA - 5 mA), the intensities currently employed in most tDCS research are ≤ 2 mA, which are sufficient to elicit measurable improvements; but, these improvements might be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate approaches to stimulation protocols were warranted. However, recent work using stimulation at higher intensities, i.e. up to 4 mA, has been performed in many populations and was found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, work exploring the differences in performance between moderate (i.e. 2 mA) and higher (i.e. 4 mA) intensities is necessary to determine if increasing intensity increases the effectiveness of the desired outcome. Prospective participants will include 40 healthy young adults (all right-side dominant) that will be recruited to complete four randomly ordered stimulation sessions (Baseline, 2 mA, 4 mA, and sham), separated by at least 5 days. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. We expect data collection to last 6 months. The first session includes leg strength measurements and fatigue tasks of both legs, as well as a baseline 6 min walk test (6MWT) to determine fatigued walking characteristics. The following three sessions will include performing a random tDCS condition (2 mA, 4 mA, or sham) over the brain area that controls the participant's dominant leg for 15 minutes prior to and then throughout the duration of the fatigue task of the dominant leg (16-20 min total stimu
Interventions
- DEVICE Sham transcranial direct current stimulation
- DEVICE Transcranial direct current stimulation at 2 mA
- DEVICE Transcranial direct current stimulation at 4 mA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2019-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04321304
The ClinicalTrials.gov registry entry for NCT04321304 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham transcranial direct current stimulation is the first listed.
NCT04321304 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04321304 about?
NCT04321304 is a clinical study titled "Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults". Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Although many tDCS devices are capable of a range of stimulation intensities (e...
What is the current status of trial NCT04321304?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2019-05-01. Estimated completion is 2019-09-01.
What interventions are being tested in trial NCT04321304?
The interventions under investigation include: Sham transcranial direct current stimulation (DEVICE), Transcranial direct current stimulation at 2 mA (DEVICE), Transcranial direct current stimulation at 4 mA (DEVICE).
Who is sponsoring clinical trial NCT04321304?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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