Ischemic Stroke
Conditions
Keywords
Post-stroke motor recovery, Individual alpha frequency(IAF), Repetitive transcranial magnetic stimulation(rTMS), Neuroplasticity
Brief summary
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.
Interventions
DEVICEActive 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 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.
DEVICESham 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 the magnetic field from directly penetrating and stimulating the cerebral cortex
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale(NIHSS) | Baseline, end of Week 2, and end of Week 4 | Minimum and Maximum Values： 0 to 42. Higher scores mean a worse outcome. |
| Fugl-Meyer Assessment-Upper Extremity(FMA-UE) | Baseline, end of Week 2, and end of Week 4 | Minimum and Maximum Values： 0 to 66. Higher scores mean a better motor function. |
| Fugl-Meyer Assessment-Lower Extremity(FMA-LE) | Baseline, end of Week 2, and end of Week 4 | Minimum and Maximum Values： 0 to 34. Higher scores mean a better motor function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalography | Baseline, end of Week 2, and end of Week 4 | global and local alpha spectral power |
| Modified Rankin Scale(mRS) | Baseline, end of Week 2, and end of Week 4 | Minimum and Maximum Values： 0 to 6. Higher scores mean a worse outcome. |
| Modified Ashworth Scale(MAS) | Baseline, end of Week 2, and end of Week 4 | Minimum and Maximum Values： 0 to 4. It grades spasticity from no increase in muscle tone (0) to rigid limbs (4) |
| EQ-5D quality of life questionnaire | Baseline, end of Week 2, and end of Week 4 | EQ VAS (Visual Analog Scale): 0 to 100. Higher scores mean a better quality of life. |
Countries
Taiwan
Contacts
CONTACTJhih-Yong Yang
Outcome results
None listed