NCT06088914 Behavioral and Neural Correlates of Post-Stroke Fatigue
| NCT ID | NCT06088914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas Woman's University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2023-12-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Hui-Ting Goh
PRINCIPAL INVESTIGATOR
Physical Therapy
Frequently Asked Questions
Who can join the NCT06088914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06088914 currently recruiting?
Yes, NCT06088914 is actively recruiting participants. Contact the research team at HGoh1@twu.edu for enrollment information.
Where is the NCT06088914 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06088914 clinical trial?
NCT06088914 is sponsored by Texas Woman's University. The principal investigator is Hui-Ting Goh at Physical Therapy. The trial plans to enroll 32 participants.
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