Behavioral and Neural Correlates of Post-Stroke Fatigue
Running, not enrolling · Not applicable · Has a placebo group
Conditions studied: Stroke, Fatigue
In brief
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.
Key facts
- Study ID
- NCT06088914
- Run by
- Texas Woman's University
- People needed
- 32
- Starts
- 2023-12-15
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Texas Woman's University — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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