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: 1. Does IAF-based rTMS improve upper and lower limb motor recovery better than a sham (placebo) stimulation? 2. How does this personalized stimulation affect brain wave activity (cortical oscillatory dynamics) as measured by EEG? 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: 1. Be randomly assigned to one of two sequences: receiving two weeks of active IAF-rTMS followed by two weeks of sham stimulation, or vice versa. 2. Attend 30-minute brain stimulation sessions, targeted at the motor cortex, 5 days a week for a total of 4 weeks. 3. Undergo clinical motor function assessments (including NIHSS, FMA-UE, and FMA-LE) and EEG recordings at three time points: at baseline, after 2 weeks, and at the end of the 4-week study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
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.
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
Department of neurology, National Taiwan Univeristy Hospital Yunlin branch
Douliu, Yunlin County, Taiwan
National Institutes of Health Stroke Scale(NIHSS)
Minimum and Maximum Values： 0 to 42. Higher scores mean a worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, end of Week 2, and end of Week 4
Electroencephalography
global and local alpha spectral power
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Baseline, end of Week 2, and end of Week 4
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