NCT05487131

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 up to 6 experimental sessions. Fatigability and motor function will be assessed in each test session.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

August 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

June 3, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

August 2, 2022

Last Update Submit

April 3, 2026

Conditions

Keywords

Transcutaneous spinal direct current stimulationTsDCSFatigability

Outcome Measures

Primary Outcomes (3)

  • Force

    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

    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

    Electromyography will be used to quantify muscle activation

    Each session will take approximately 2 hours (total of 4 test sessions)

Study Arms (2)

Men

EXPERIMENTAL

Individuals will participate in 1 familiarization and up to 6 test sessions

Behavioral: electrical stimulation

Women

EXPERIMENTAL

Individuals will participate in 1 familiarization and up to 6 test sessions

Behavioral: electrical stimulation

Interventions

different types of low-intensity (comfortable) electrical stimulation will be used and applied in distinct locations

MenWomen

Eligibility Criteria

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

You may qualify if:

  • Healthy individuals between 18 and 50 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma

Norman, Oklahoma, 73071, United States

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Hugo Pereira, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Pereira, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 4, 2022

Study Start

June 3, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations