- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05487131
Neuromodulation and Fatigue
April 3, 2026 updated by: University of Oklahoma
Neuromodulation and Its Effects on Muscle Activity and Fatigue
In this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation.
Healthy individuals will participate in one familiarization followed by up to 6 experimental sessions.
Fatigability and motor function will be assessed in each test session.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This project will investigate the potential impact of an electrical current of low intensity, and applied non-invasively, on the signals that drive muscle contractions.
Individuals will receive distinct types of stimulation that vary depending on the direction on the current (anodal vs cathodal) and placement of the electrodes.
These conditions will be compared to a sham stimulation.
The test session will be randomized in a double blind fashion, which indicates that neither participants or investigators will know the type of stimulation.
Motor function and the muscle electrical activity will be quantified during each test session.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hugo Pereira, PhD
- Phone Number: 405-325-2773
- Email: hugomax@ou.edu
Study Locations
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73071
- Recruiting
- University of Oklahoma
-
Contact:
- Hugo Pereira, PhD
- Phone Number: 405-325-2773
- Email: hugomax@ou.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Healthy individuals between 18 and 50 years old
Exclusion Criteria:
Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Men
Individuals will participate in 1 familiarization and up to 6 test sessions
|
different types of low-intensity (comfortable) electrical stimulation will be used and applied in distinct locations
|
|
Experimental: Women
Individuals will participate in 1 familiarization and up to 6 test sessions
|
different types of low-intensity (comfortable) electrical stimulation will be used and applied in distinct locations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Force
Time Frame: Each session will take approximately 2 hours (total of 4 test sessions)
|
Change in force will be evaluated with a device during each test session
|
Each session will take approximately 2 hours (total of 4 test sessions)
|
|
Perception of effort
Time Frame: Each session will take approximately 2 hours (total of 4 test sessions)
|
Change in perceived effort will be evaluated with visual analogue scales
|
Each session will take approximately 2 hours (total of 4 test sessions)
|
|
Muscle activation
Time Frame: Each session will take approximately 2 hours (total of 4 test sessions)
|
Electromyography will be used to quantify muscle activation
|
Each session will take approximately 2 hours (total of 4 test sessions)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hugo Pereira, PhD, University of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 2, 2022
First Submitted That Met QC Criteria
August 2, 2022
First Posted (Actual)
August 4, 2022
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14921P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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