Ischemic StrokeNCT07498777
Individual Alpha Frequency-Based rTMS for Post-Stroke Motor Recovery: Efficacy and Neurophysiological Mechanisms
A study testing Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS) in people with Ischemic Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of neurology, National Taiwan Univeristy Hospital Yunlin branch
Douliu, Yunlin County, 640
Jhih-Yong Yang, 886-972-653-077, johnny2003123@gmail.com
About this study
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:
Read more
- 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.
- Conditions
- Ischemic Stroke
- Being tested
- Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS), Sham Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS)
- Keywords
- Post-stroke motor recovery, Individual alpha frequency(IAF), Repetitive transcranial magnetic stimulation(rTMS), Neuroplasticity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Active IAF-rTMS followed by Sham rTMS | Experimental | Not described Receives: 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 | Not described Receives: Device: Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS); Device: Sham Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale(NIHSS)
Minimum and Maximum Values： 0 to 42. Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: Baseline, end of Week 2, and end of Week 4
Secondary outcomes (4)
Electroencephalography
global and local alpha spectral power
Measured: Baseline, end of Week 2, and end of Week 4
Modified Rankin Scale(mRS)
Minimum and Maximum Values： 0 to 6. Higher scores mean a worse outcome.
Measured: Baseline, end of Week 2, and end of Week 4
Modified Ashworth Scale(MAS)
Minimum and Maximum Values： 0 to 4. It grades spasticity from no increase in muscle tone (0) to rigid limbs (4)
Measured: Baseline, end of Week 2, and end of Week 4
EQ-5D quality of life questionnaire
EQ VAS (Visual Analog Scale): 0 to 100. Higher scores mean a better quality of life.
Measured: Baseline, end of Week 2, and end of Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498777
- Sponsor's protocol ID
- 202510112DINC
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data covering demographic characteristics, clinical assessments (NIHSS, FMA-UE, FMA-LE, mRS, MAS, EQ-5D scores)
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Alpha Frequency-Based rTMS for Post-Stroke Motor Recovery: Efficacy and Neurophysiological Mechanisms
- ClinicalTrials.gov ID
- NCT07498777
- Acronym / sponsor ID
- 202510112DINC
- Conditions
- Ischemic Stroke
- Keywords
- Post-stroke motor recovery, Individual alpha frequency(IAF), Repetitive transcranial magnetic stimulation(rTMS), Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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)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 | Device | Active IAF-rTMS followed by Sham rTMS, Sham rTMS followed by Active IAF-rTMS |
Primary outcome
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.
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.
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.
4 secondary outcomes
Electroencephalography
Time frame: 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
Modified Ashworth Scale(MAS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data covering demographic characteristics, clinical assessments (NIHSS, FMA-UE, FMA-LE, mRS, MAS, EQ-5D scores)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Individual Alpha Frequency-based Repetitive Transcranial Magnetic Stimulation (IAF-rTMS) in people with Ischemic Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jhih-Yong Yang (Taiwan, 886-972-653-077, johnny2003123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale(NIHSS) (time frame: Baseline, end of Week 2, and end of Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.