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The goal of this clinical trial is to evaluate the efficacy of a personalized brain stimulation technique, Individual Alpha Frequency (IAF)-based rTMS, for motor function recovery in adult patients with a first-ever ischemic stroke.
The main questions it aims to answer are:
Researchers will compare active IAF-based rTMS with a sham stimulation control in a crossover design to see if the active treatment leads to better clinical motor outcomes and beneficial changes in brain activity.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active IAF-rTMS followed by Sham rTMS | Experimental |
| |
| Sham rTMS followed by Active IAF-rTMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS) | Device | Participants will receive Individual Alpha Frequency (IAF)-guided repetitive transcranial magnetic stimulation (rTMS) targeted at the ipsilesional primary motor cortex (M1). The stimulation frequency will be tailored to each participant's intrinsic IAF (ranging from 8 to 12 Hz). If the ipsilesional IAF is not available, the contralesional alpha frequency will be utilized. The stimulation intensity is set at 100% of the resting motor threshold (RMT). The protocol consists of a 2.5-second train duration followed by a 10-second inter-train interval. Each daily session lasts for 30 minutes, delivering a total of 2,880 to 4,320 magnetic pulses per session. |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale(NIHSS) | Minimum and Maximum Values: 0 to 42. Higher scores mean a worse outcome. | Baseline, end of Week 2, and end of Week 4 |
| Fugl-Meyer Assessment-Upper Extremity(FMA-UE) | Minimum and Maximum Values: 0 to 66. Higher scores mean a better motor function. | Baseline, end of Week 2, and end of Week 4 |
| Fugl-Meyer Assessment-Lower Extremity(FMA-LE) | Minimum and Maximum Values: 0 to 34. Higher scores mean a better motor function. | Baseline, end of Week 2, and end of Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalography | global and local alpha spectral power | Baseline, end of Week 2, and end of Week 4 |
| Modified Rankin Scale(mRS) | Minimum and Maximum Values: 0 to 6. Higher scores mean a worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Related Adverse Events | From Baseline up to Week 16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jhih-Yong Yang | Contact | Taiwan, 886-972-653-077 | johnny2003123@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, National Taiwan Univeristy Hospital Yunlin branch | Douliu | Yunlin County | 640 | Taiwan |
De-identified individual participant data covering demographic characteristics, clinical assessments (NIHSS, FMA-UE, FMA-LE, mRS, MAS, EQ-5D scores)
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Beginning 6 months and ending 24 months following article publication.
Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement and obtain local IRB approval.
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|
| Sham Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS) | Device | Participants will receive sham rTMS using the identical device and stimulation parameters (100% RMT intensity, 2.5-second train, 10-second interval, 30-minute session duration) targeted at the same anatomical site (ipsilesional M1). To achieve the sham condition, the stimulation coil will be tilted at a 90-degree angle (one-wing 90° method) away from the scalp. This specific coil placement produces the same acoustic click and similar somatic sensations as the active treatment, while preventing the magnetic field from directly penetrating and stimulating the cerebral cortex |
|
| Baseline, end of Week 2, and end of Week 4 |
| Modified Ashworth Scale(MAS) | Minimum and Maximum Values: 0 to 4. It grades spasticity from no increase in muscle tone (0) to rigid limbs (4) | Baseline, end of Week 2, and end of Week 4 |
| EQ-5D quality of life questionnaire | EQ VAS (Visual Analog Scale): 0 to 100. Higher scores mean a better quality of life. | Baseline, end of Week 2, and end of Week 4 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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