Neuromodulation and Fatigue

• Sponsor: University of Oklahoma (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05487131
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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 three experimental sessions. Fatigability and motor function will be assessed in each test session.

Condition or Disease	Intervention/Treatment	Phase
Healthy Aging; Fatigue	Behavioral: electrical stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Neuromodulation and Fatigue
• Anticipated Study Start Date: Sep 30, 2022
• Anticipated Primary Completion Date: Sep 29, 2024
• Anticipated Study Completion Date: Dec 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Men Individuals will participate in 1 familiarization and 3 test sessions	Behavioral: electrical stimulation; different types of weak electrical stimulation will be used
Experimental: Women Individuals will participate in 1 familiarization and 3 test sessions	Behavioral: electrical stimulation; different types of weak electrical stimulation will be used

Outcome Measures

Primary Outcome Measures

1. Force [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

2. Perception of effort [Each session will take approximately 2 hours (total of 4 test sessions)]

   Change in perceived effort will be evaluated with visual analogue scales

3. Muscle activation [Each session will take approximately 2 hours (total of 4 test sessions)]

   Electromyography will be used to quantify muscle activation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Healthy individuals between 18 and 50 years old

Exclusion Criteria:

Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma	Norman	Oklahoma	United States	73071

Sponsors and Collaborators

• University of Oklahoma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT05487131
• Other Study ID Numbers: 14921
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Oklahoma: Transcutaneous spinal direct current stimulation; TsDCS; Fatigability
• Additional relevant MeSH terms: Fatigue

Study Results

No Results Posted as of Aug 4, 2022