NCT06389162

Brief 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. 1.Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained?
  2. 2.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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 24, 2024

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time to Task Failure

    The time in seconds that a fatiguing contraction can be held

    5 months

  • Fatigue Index

    The percent decline in force between the maximum voluntary contractions performed before and after the fatiguing contraction

    5 months

Secondary Outcomes (4)

  • Average EMG activity

    5 months

  • Force error

    5 months

  • Standard deviation of force

    5 months

  • 9 Hole Pegboard Test

    5 months

Study Arms (2)

tDCS

EXPERIMENTAL

Transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex

Device: transcranial direct current stimulation

SHAM

SHAM COMPARATOR

SHAM transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex

Device: transcranial direct current stimulation

Interventions

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.

SHAMtDCS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Not done a similar fatigue study in the laboratory in the last 7 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

April 4, 2024

Primary Completion

August 31, 2024

Study Completion

September 30, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations