FatigueNCT06389162
Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue
A study testing transcranial direct current stimulation in people with Fatigue, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
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: 1. Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained? 2. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: 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.
Read more
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.
Read the detailed description
Transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC) can increase endurance time in lower body tasks. Therefore, the purpose of this study is to examine the effect of DLPFC-tDCS on the time to task failure (TTF) of a fatiguing contraction performed by hand muscles. The study will use a double-blind, randomized, SHAM-controlled, crossover design with each participant performing two experimental sessions held 3-7 days apart. The only difference between the two sessions will be the type of stimulation (tDCS or SHAM; counterbalanced) applied concurrent with the fatiguing contraction. The fatiguing contraction will involve gripping a manipulandum with the index finger and thumb. This will be accomplished by using a precision grip and matching an isometric target equal to 15% of the maximum voluntary contraction (MVC) for as long as possible until task failure.
- Conditions
- Fatigue
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex Receives: Device: transcranial direct current stimulation |
| SHAM | Sham comparator | SHAM transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Task Failure
The time in seconds that a fatiguing contraction can be held
Measured: 5 months
Fatigue Index
The percent decline in force between the maximum voluntary contractions performed before and after the fatiguing contraction
Measured: 5 months
Secondary outcomes (4)
Average EMG activity
The average EMG activity of the first dorsal interosseus muscle during the fatiguing contraction.
Measured: 5 months
Force error
The average force error during the fatiguing contraction.
Measured: 5 months
Standard deviation of force
The average standard deviation of force during the fatiguing contraction.
Measured: 5 months
9 Hole Pegboard Test
9 Hole Pegboard Test time before and after the fatiguing contraction
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start4 Apr 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brach Poston, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389162
- Sponsor's protocol ID
- UNLV-2024-115
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dorsolateral Prefrontal Cortex Transcranial Direct Current Stimulation on Muscle Fatigue
- ClinicalTrials.gov ID
- NCT06389162
- Acronym / sponsor ID
- UNLV-2024-115
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC) can increase endurance time in lower body tasks. Therefore, the purpose of this study is to examine the effect of DLPFC-tDCS on the time to task failure (TTF) of a fatiguing contraction performed by hand muscles. The study will use a double-blind, randomized, SHAM-controlled, crossover design with each participant performing two experimental sessions held 3-7 days apart. The only difference between the two sessions will be the type of stimulation (tDCS or SHAM; counterbalanced) applied concurrent with the fatiguing contraction. The fatiguing contraction will involve gripping a manipulandum with the index finger and thumb. This will be accomplished by using a precision grip and matching an isometric target equal to 15% of the maximum voluntary contraction (MVC) for as long as possible until task failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: transcranial direct current stimulationTranscranial direct current stimulation applied to the left dorsolateral prefrontal cortex |
| SHAM | Sham comparator | Device: transcranial direct current stimulationSHAM transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationTranscranial direct current stimulation is a type of non-invasive brain stimulation that involves passing a weak current between two electrodes placed on the scalp. | Device | SHAM, tDCS |
Primary outcome
Time to Task Failure
Time frame: 5 months
The time in seconds that a fatiguing contraction can be held
Fatigue Index
Time frame: 5 months
The percent decline in force between the maximum voluntary contractions performed before and after the fatiguing contraction
4 secondary outcomes
Average EMG activity
Time frame: 5 months
Force error
Time frame: 5 months
Standard deviation of force
Time frame: 5 months
9 Hole Pegboard Test
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Fatigue, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Task Failure (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.