- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06389162
Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue
The Influence of Dorsolateral Prefrontal Cortex Transcranial Direct Current Stimulation on Muscle Fatigue
The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) can impact muscle fatigue. The main questions it aims to answer are:
- Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained?
- Does tDCS of the left DLPFC decrease the rate of increase of muscle activity, force error, and standard deviation of force during a fatiguing contraction.
Researchers will compare tDCS of the left DLPFC to a SHAM stimulation (a type of stimulation that feels like real tDCS but does not elicit physiological effects) to see if tDCS of the left DLPFC works to reduce the progression of muscle fatigue.
Participants will:
Performing two experimental sessions held 3-10 days apart (usually 7 days) Perform a 9 hole pegboard test, maximum voluntary contractions, and a fatiguing contraction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89154
- University of Nevada Las Vegas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to provide informed consent
- Free from any neurological or psychiatric condition
- Age between 18-50 years old
- Right-handed (as determined by the Edinburgh Handedness Inventory)
Exclusion Criteria:
- An uncontrolled medical condition (i.e. hypertension, diabetes, etc)
- Metal in the skull or the eye, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, and metal fragments in the eye.
- Hearing loss diagnosed by a doctor and requiring a hearing aid. Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures, have a neurological disorder, a movement disorder, or have a head injury that involved being passed out for more than a few seconds.
- History of migraines
- implanted defibrillator or implanted neurostimulator
- pregnant or thought to be pregnant. This must be an exclusion criterion as there are few medical papers available regarding the effects of tDCS on the unborn child/fetus or expectant mother. Thus, if you are pregnant or thought to be pregnant you cannot participate in the study. If you find out you are pregnant in the week timeframe between experiment 1 and experiment 2, you should withdraw from the study as we cannot perform the second experiment in that case.
- Not done a similar fatigue study in the laboratory in the last 7 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tDCS
Transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex
|
Transcranial direct current stimulation is a type of non-invasive brain stimulation that involves passing a weak current between two electrodes placed on the scalp.
|
|
Sham Comparator: SHAM
SHAM transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex
|
Transcranial direct current stimulation is a type of non-invasive brain stimulation that involves passing a weak current between two electrodes placed on the scalp.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Task Failure
Time Frame: 5 months
|
The time in seconds that a fatiguing contraction can be held
|
5 months
|
|
Fatigue Index
Time Frame: 5 months
|
The percent decline in force between the maximum voluntary contractions performed before and after the fatiguing contraction
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average EMG activity
Time Frame: 5 months
|
The average EMG activity of the first dorsal interosseus muscle during the fatiguing contraction.
|
5 months
|
|
Force error
Time Frame: 5 months
|
The average force error during the fatiguing contraction.
|
5 months
|
|
Standard deviation of force
Time Frame: 5 months
|
The average standard deviation of force during the fatiguing contraction.
|
5 months
|
|
9 Hole Pegboard Test
Time Frame: 5 months
|
9 Hole Pegboard Test time before and after the fatiguing contraction
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNLV-2024-115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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