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Recruiting NCT06088914

Behavioral and Neural Correlates of Post-Stroke Fatigue

Trial Parameters

Condition Stroke
Sponsor Texas Woman's University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-15
Completion 2026-08-31
All Conditions
Interventions
Anodal transcranial direct current stimulationSham transcranial direct current stimulation

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: 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.

Eligibility Criteria

Inclusion Criteria: 1. be at least 18 years old; 2. have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability; 3. have an average score ≥ 4 on FSS; 4. have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task; 5. be able to follow three-step commands. Exclusion Criteria: 1. acute medical problems; 2. the presence of any contraindication to tDCS, MRI or TMS; 3. the presence of significant depression (score \> 10 on the Patient Health Questionnaire-9); 4. significant pain in the upper extremities that interferes with movements; or 5. use of medication which may affect the level of fatigue.

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