NCT06270238 Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients
| NCT ID | NCT06270238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-13 |
| Primary Completion | 2026-09-30 |
Trial Parameters
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Brief Summary
The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
Eligibility 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.
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