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

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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