Effects of brain stimulation on fatigue after stroke
Behavioral and Neural Correlates of Post-Stroke Fatigue
This study is testing if a type of brain stimulation can help people who feel tired after a stroke feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Texas Woman's University Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06088914 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the behavioral and neural effects of five daily sessions of anodal transcranial direct current stimulation (tDCS) on individuals experiencing post-stroke fatigue (PSF). Participants will be randomly assigned to receive either real or sham stimulation, and their fatigue levels will be assessed before, immediately after, and one month post-intervention. The study will utilize clinical assessments, transcranial magnetic stimulation, and resting state functional MRI to investigate the relationship between brain excitability, connectivity, and changes in fatigue. The goal is to better understand the mechanisms behind PSF and evaluate the efficacy of tDCS as a potential treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a unilateral stroke at least three months prior and exhibit significant fatigue.
Not a fit: Patients with acute medical issues, significant depression, or contraindications to tDCS, MRI, or TMS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel intervention to alleviate post-stroke fatigue, improving the quality of life for stroke survivors.
How similar studies have performed: While some studies have explored brain stimulation for fatigue, the specific approach of using tDCS for post-stroke fatigue is relatively novel and has shown mixed results in previous trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas
- Texas Woman's University — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Hui-Ting Goh — Physical Therapy
- Study coordinator: Hui-Ting Goh
- Email: HGoh1@twu.edu
- Phone: 4697405662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.