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

National Taiwan University

Status

Not yet enrolling

Conditions

Ischemic Stroke

Treatments

Device: Sham Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)

Device: Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT07498777

202510112DINC

Details and patient eligibility

About

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:

Does IAF-based rTMS improve upper and lower limb motor recovery better than a sham (placebo) stimulation?
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:

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.
Attend 30-minute brain stimulation sessions, targeted at the motor cortex, 5 days a week for a total of 4 weeks.
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.

Enrollment

34 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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