Using brain stimulation to reduce fatigue after a stroke
Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)
This study is testing whether a brain stimulation treatment can help reduce fatigue in people who have had a stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05816603 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial direct current stimulation (tDCS) as a non-drug treatment for post-stroke fatigue. It involves a double-blind, sham-controlled, randomized design with 24 participants, where half will receive real stimulation and the other half will receive a placebo. The tDCS device will be applied daily for 20 minutes over a two-week period, with follow-up assessments to evaluate fatigue severity and neuroimaging to observe brain changes. The goal is to determine if this intervention can effectively reduce fatigue in stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are more than three months post-stroke and experience severe fatigue.
Not a fit: Patients with a history of seizures, severe depression, or significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate fatigue in stroke survivors, improving their quality of life.
How similar studies have performed: Other studies using tDCS for various neurological conditions have shown promising results, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients aged \>18 years * Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI). * Fatigue severity score average \>4 (severe fatigue) * Willingness to remain stable on pharmacologic therapy through the duration of the study. * Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention. Exclusion Criteria: * Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator) * History of seizure * History of moderate to severe traumatic brain injury * A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety. * A score of less than 21 on the MoCA suggesting major neurocognitive disorder. * Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied. * Inability to provide informed consent * Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
Where this trial is running
New York, New York
- Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106 — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Joan M Stilling, MD, MS — Weill Medical College of Cornell University
- Study coordinator: Zhiyan Yang, M.A.
- Email: rehabresearch@med.cornell.edu
- Phone: (212) 746-1509
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.