Individual Alpha Frequency-Based rTMS for Post-Stroke Motor Recovery: Efficacy and Neurophysiological Mechanisms

Обзор

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.

Вмешательства

• Устройство Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)
  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 du
• Устройство Sham Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)
  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 t

Первичные конечные точки

• National Institutes of Health Stroke Scale(NIHSS) [Срок оценки: Baseline, end of Week 2, and end of Week 4]
• Fugl-Meyer Assessment-Upper Extremity(FMA-UE) [Срок оценки: Baseline, end of Week 2, and end of Week 4]
• Fugl-Meyer Assessment-Lower Extremity(FMA-LE) [Срок оценки: Baseline, end of Week 2, and end of Week 4]

Вторичные конечные точки (4)

• Electroencephalography [Срок оценки: Baseline, end of Week 2, and end of Week 4]
• Modified Rankin Scale(mRS) [Срок оценки: Baseline, end of Week 2, and end of Week 4]
• Modified Ashworth Scale(MAS) [Срок оценки: Baseline, end of Week 2, and end of Week 4]
• EQ-5D quality of life questionnaire [Срок оценки: Baseline, end of Week 2, and end of Week 4]

Критерии участия

Критерии включения

• Age >18
• First ischemic stroke patient, confirmed by brain MRI
• Has not received repetitive transcranial magnetic stimulation (rTMS) treatment after this stroke episode
• Cortical, subcortical infarction with motor impairment
• Baseline ADL intact (Full score of pre-stroke Barthel Index)
• Clear consciousness and with the ability to understand and cooperate with the study
• NIHSS 5-20, or FMA-UE 20-50, or FMA-LE 15-25
• Within 2 to 12 weeks after stroke onset
• Participants had received stable treatment prior to the trial or were evaluated by a physician as having an inadequate response to conventional rehabilitation therapy

Критерии исключения

• Hemorrhagic transformation in the brain
• Unstable condition
• Stroke primarily caused by cancer-related hypercoagulability or autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome)
• Known previous peripheral nerve injury or peripheral neuropathy on the affected side that impairs mobility
• Individual history of epilepsy
• Presence of cardiac pacemakers, cochlear implants, drug delivery pumps, implantable cardioverter-defibrillators, implanted neurostimulators, or other metal objects in the body. This also includes patients who have undergone cranioplasty or have other implanted devices incompatible with rTMS
• Pregnancy
• Multiple sclerosis patient
• Use of tricyclic antidepressants or other medications that may lower the seizure threshold
• Severe alcoholism
• Hamilton Depression Rating Scale suicide item score ≥ 2
• Patients with skin lesions or damage at the intended site of stimulation.
• Family history of epilepsy
• Patients with brain injuries that may affect the seizure threshold
• Patients who develop sleep disorders during the course of rTMS treatment
• Patients currently using anti-epileptic drugs
• Patients with severe heart disease or patients with uncontrolled migraines caused by increased intracranial pressure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Department of neurology, National Taiwan Univeristy Hospital Yunlin branch — Douliu

Идентификаторы

NCT: NCT07498777 · 202510112DINC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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