Actively Recruiting
Behavioral and Neural Correlates of Post-Stroke Fatigue
Led by Texas Woman's University · Updated on 2024-10-16
32
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
T
Texas Woman's University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF. Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1. Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF. Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes.
CONDITIONS
Official Title
Behavioral and Neural Correlates of Post-Stroke Fatigue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old
- Have a history of unilateral stroke at least 3 months before enrollment
- Have an average Fatigue Severity Scale score of 4 or higher
- Have some movement ability in the affected arm (upper extremity Fugl-Meyer score 28 or above)
- Be able to follow three-step commands
You will not qualify if you...
- Have any acute medical problems
- Have any contraindications to transcranial direct current stimulation, MRI, or transcranial magnetic stimulation
- Have significant depression (Patient Health Questionnaire-9 score greater than 10)
- Have significant pain in the upper extremities that interferes with movement
- Use medications that may affect fatigue levels
AI-Screening
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Trial Site Locations
Total: 1 location
1
Texas Woman's University
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
H
Hui-Ting Goh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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