Status:
RECRUITING
Behavioral and Neural Correlates of Post-Stroke Fatigue
Lead Sponsor:
Texas Woman's University
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Stroke
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are: Aim 1: Inve...
Detailed Description
Up to 85% stroke survivors experience post-stroke fatigue (PSF) defined as intensified perceived effort during activities. PSF is a significant barrier to full participation in rehabilitation and nega...
Eligibility Criteria
Inclusion
- be at least 18 years old;
- have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability;
- have an average score ≥ 4 on FSS;
- have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task;
- be able to follow three-step commands.
Exclusion
- acute medical problems;
- the presence of any contraindication to tDCS, MRI or TMS;
- the presence of significant depression (score \> 10 on the Patient Health Questionnaire-9);
- significant pain in the upper extremities that interferes with movements; or
- use of medication which may affect the level of fatigue.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06088914
Start Date
December 15 2023
End Date
August 31 2026
Last Update
October 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Woman's University
Dallas, Texas, United States, 75235