About this trial
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
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- Anodal transcranial direct current stimulation
- Sham transcranial direct current stimulation
Treatment groups
Sponsors and collaborators
Texas Woman's University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator