Personalized brain stimulation for stroke recovery
Personalized Transcranial Direct Current Stimulation in Stroke Recovery
This study is testing if a personalized brain stimulation treatment can help people who have had a stroke recover better and improve movement in their affected arm during therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06286800 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of personalized transcranial direct current stimulation (ptDCS) on stroke recovery by assessing its impact on brain connectivity and clinical improvement. It involves a randomized, sham-controlled, double-masked design where chronic stroke patients receive either active or sham stimulation during occupational therapy sessions. The goal is to determine if the personalized stimulation can enhance neural plasticity and improve motor function in the affected arm. Patients will have the option to crossover to receive the active treatment after an initial follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced a stroke more than three months prior and have some degree of hemiparesis.
Not a fit: Patients with severe cognitive deficits, bilateral paresis, or those with significant psychiatric or medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved rehabilitation outcomes for stroke patients by enhancing brain recovery mechanisms.
How similar studies have performed: Previous studies have shown promise with transcranial direct current stimulation in stroke recovery, suggesting potential for this personalized approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4). * Age more than 18, Male or Female, All racial and ethnic groups * Entry into the study \>3 months post onset * Modified Ashworth Scale Score \<3 in the involved upper extremity * Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand * Able to follow 2 step commands Exclusion Criteria: * Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions). * Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.) * Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age,epilepsy or others). * Patients with unstable cardiac arrhythmia. * Pregnancy * Patients with metallic implants in the head, patients with pacemakers, patients with craniotomies, including burr holes who cannot be safely stimulated * Patients with seizures * Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services.
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Timea Hodics, MD — The Methodist Hospital Research Institute
- Study coordinator: Neha Sudarshan, MD
- Email: nsudarshan@houstonmethodist.org
- Phone: 9082277275
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.