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

March 23, 2026 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Yunlin County
      • Douliu, Yunlin County, Taiwan, 640
        • Department of neurology, National Taiwan Univeristy Hospital Yunlin branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active IAF-rTMS followed by Sham rTMS
Device: 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 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.
Device: 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 the magnetic field from directly penetrating and stimulating the cerebral cortex
Experimental: Sham rTMS followed by Active IAF-rTMS
Device: 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 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.
Device: 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 the magnetic field from directly penetrating and stimulating the cerebral cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale(NIHSS)
Time Frame: Baseline, end of Week 2, and end of Week 4
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)
Time Frame: Baseline, end of Week 2, and end of Week 4
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)
Time Frame: Baseline, end of Week 2, and end of Week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography
Time Frame: Baseline, end of Week 2, and end of Week 4
global and local alpha spectral power
Baseline, end of Week 2, and end of Week 4
Modified Rankin Scale(mRS)
Time Frame: Baseline, end of Week 2, and end of Week 4
Minimum and Maximum Values： 0 to 6. Higher scores mean a worse outcome.
Baseline, end of Week 2, and end of Week 4
Modified Ashworth Scale(MAS)
Time Frame: 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)
Baseline, end of Week 2, and end of Week 4
EQ-5D quality of life questionnaire
Time Frame: 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.
Baseline, end of Week 2, and end of Week 4

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of Treatment-Related Adverse Events
Time Frame: From Baseline up to Week 16
From Baseline up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202510112DINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data covering demographic characteristics, clinical assessments (NIHSS, FMA-UE, FMA-LE, mRS, MAS, EQ-5D scores)

IPD Sharing Time Frame

Beginning 6 months and ending 24 months following article publication.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe