Behavioral and Neural correlates of Post-STROKE Fatigue: A randomized controlled trial protocol.
Kuan-Chun Liao, Isabelle Christian, Jill Stewart...
https://pubmed.ncbi.nlm.nih.gov/40478794Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06088914
Behavioral and Neural Correlates of Post-Stroke Fatigue Using Anodal Transcranial Direct Current Stimulation
Led by Texas Woman's University · Updated on 2024-10-16
32
Participants Needed
1
Research Sites
N/A
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
This research aims to understand the behavioral and brain-related effects of five daily sessions of transcranial direct current stimulation (tDCS) on fatigue experienced after a stroke. The study focuses on exploring how stimulating the primary motor cortex (M1) affects post-stroke fatigue (PSF) and the brain's activity. It will clarify the connections between brain excitability, brain network activity, and fatigue symptoms to guide future treatments. Participants will be randomly assigned to one of two groups: one receiving real anodal tDCS and the other receiving sham (placebo) stimulation. The tDCS is applied to the side of the brain affected by the stroke at 2 mA for 20 minutes over five consecutive days. The sham group receives a brief stimulation that quickly ramps down to mimic the experience without active treatment. During the study, fatigue and brain function will be assessed before treatment, immediately after the five-day intervention, and one month later. Assessments include clinical fatigue scales, behavioral tests, brain excitability measured by transcranial magnetic stimulation, and brain connectivity examined by resting-state functional MRI. These measures will help evaluate treatment effects and their relationship to brain changes over time.
CONDITIONS
Brief Title
Behavioral and Neural Correlates of Post-Stroke Fatigue
Who Can Participate
Age: 18Years +
All Genders
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 score of 4 or higher on the Fatigue Severity Scale
- Have some movement ability in the more affected arm (upper extremity Fugl-Meyer score 28 or higher)
- Be able to follow three-step commands
You will not qualify if you...
- Have acute medical problems
- Have any contraindications to tDCS, MRI, or transcranial magnetic stimulation
- Have significant depression (score greater than 10 on Patient Health Questionnaire-9)
- Have significant pain in the upper extremities that interferes with movement
- Use medications that may affect fatigue levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 consecutive days
Participants receive five consecutive daily sessions of either anodal or sham transcranial direct current stimulation (tDCS) applied to the ipsilesional primary motor cortex to investigate its effects on post-stroke fatigue.
5 visits (in-person, daily)
Follow-up
Duration - Approximately 5 weeks from baseline
Participants complete assessments to evaluate the effects of treatment on fatigue and brain function approximately 5 weeks after the baseline.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Texas Woman's University
Dallas, Texas, United States, 75235
Actively Recruiting
Loading map...
Research Team
H
Hui-Ting Goh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here