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

NCT07498777 | Not Yet Recruiting

• 1 other identifier: 202510112DINC
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 1.Does IAF-based rTMS improve upper and lower limb motor recovery better than a sham (placebo) stimulation?
2. 2.How does this personalized stimulation affect brain wave activity (cortical oscillatory dynamics) as measured by EEG?
3. 3.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.
4. 4.Attend 30-minute brain stimulation sessions, targeted at the motor cortex, 5 days a week for a total of 4 weeks.
5. 5.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.

Conditions

Ischemic Stroke

Keywords

Post-stroke motor recovery; Individual alpha frequency(IAF); Repetitive transcranial magnetic stimulation(rTMS); Neuroplasticity

Outcome Measures

Primary Outcomes (3)

• National Institutes of Health Stroke Scale(NIHSS)

  Minimum and Maximum Values： 0 to 42. Higher scores mean a worse outcome.

  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.

  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.

  Baseline, end of Week 2, and end of Week 4

Secondary Outcomes (4)

• Electroencephalography

  Baseline, end of Week 2, and end of Week 4

• Modified Rankin Scale(mRS)

  Baseline, end of Week 2, and end of Week 4

• Modified Ashworth Scale(MAS)

  Baseline, end of Week 2, and end of Week 4

• EQ-5D quality of life questionnaire

  Baseline, end of Week 2, and end of Week 4

Other Outcomes (1)

• Incidence of Treatment-Related Adverse Events

  From Baseline up to Week 16

Study Arms (2)

Active IAF-rTMS followed by Sham rTMS

EXPERIMENTAL

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

Sham rTMS followed by Active IAF-rTMS

EXPERIMENTAL

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

Interventions

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

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.

Active IAF-rTMS followed by Sham rTMS; Sham rTMS followed by Active IAF-rTMS

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

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

Active IAF-rTMS followed by Sham rTMS; Sham rTMS followed by Active IAF-rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of neurology, National Taiwan Univeristy Hospital Yunlin branch

Douliu, Yunlin County, 640, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jhih-Yong Yang

CONTACT

Taiwan, 886-972-653-077; johnny2003123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months and ending 24 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement and obtain local IRB approval.

Locations

TW (1)