Personalized rTMS therapy to improve upper limb function in stroke patients
Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients: A Multi Center, Randomized, Single Blind, Parallel Group Prospective Clinical Trial
This study is testing if personalized brain stimulation can help improve arm movement in stroke patients by tailoring the treatment to their specific needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06270238 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of personalized repetitive transcranial magnetic stimulation (rTMS) protocols tailored to the functional reserve of hemiplegic stroke patients in the subacute phase. By categorizing patients based on their corticospinal tract preservation, the study aims to compare the outcomes of individualized rTMS treatment against conventional low-frequency rTMS therapy. The approach is designed to enhance motor function recovery by addressing the unique needs of each patient rather than applying a one-size-fits-all protocol. The study involves screening evaluations, including motor evoked potentials and imaging techniques, to determine the most effective stimulation targets.
Who should consider this trial
Good fit: Ideal candidates are hemiplegic stroke patients in the subacute phase, aged 19 or older, with specific functional limitations.
Not a fit: Patients with contraindications to rTMS or those with significant coexisting neurological or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved upper limb function and recovery outcomes for stroke patients.
How similar studies have performed: While traditional rTMS protocols have been widely studied, this personalized approach based on functional reserve is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized, 2. FMA score of the upper extremity ≤42, 3. adequate language and cognitive function to perform at least a 1-step obey-command, 4. pre-stroke functional level of modified Rankin Scale (mRS) ≤1, 5. aged ≥19 years old, 6. patients willing to sign the informed consent. Exclusion Criteria: 1. those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy, 2. those with progressive of hemodynamically unstable medical conditions, 3. those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease, 4. those with major psychiatric disorders, such as major depression, schizophrenia, or dementia, 5. those having contraindications to conduct an MRI study, 6. those who are pregnant or lactating , 7. patients who have refused to participate in this study.
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Won Hyuk Chang, PhD — Samsung Medical Center
- Study coordinator: Won Hyuk Chang, PhD
- Email: wh.chang@samsung.com
- Phone: 82-2-3410-6068
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.