StrokeNCT06270238
Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients
A study testing High-Frequency1, cTBS1 and High-Frequency2 in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- High-Frequency1, cTBS1 and High-Frequency2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2024to 30 Sep 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,
- FMA score of the upper extremity ≤42,
- adequate language and cognitive function to perform at least a 1-step obey-command,
- pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
- aged ≥19 years old,
- patients willing to sign the informed consent.
Who cannot join
- those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
- those with progressive of hemodynamically unstable medical conditions,
- those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
- those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
- those having contraindications to conduct an MRI study,
- those who are pregnant or lactating ,
- patients who have refused to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Won Hyuk Chang, PhD, +82-2-3410-6068, wh.chang@samsung.com
About this study
Official title: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients: A Multi Center, Randomized, Single Blind, Parallel Group Prospective Clinical Trial
The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
Read the detailed description
rTMS treatment for patients with stroke is traditionally based on interhemispheric interactions. The widely-used traditional rTMS treatment protocol involves inhibitory low-frequency or continuous theta burst stimulation (cTBS) applied over the contralesional hemisphere and excitatory high-frequency stimulation over the ipsilesional hemisphere. However, concerns have arisen regarding the effect of rTMS on motor recovery in stroke patients. Although still subject to debate, a possible reason for the diverse results of rTMS applied to stroke patients is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery.
Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each hemiplegic stroke patient.
Based on screening evaluations (TMS-induced motor evoked potential (MEP), diffusion tensor imaging (DTI), MRI), investigators hypothesized that patients could be categorized into three groups: 1) preserved ipsilateral corticospinal tract, 2) preserved ipsilateral alternative corticospinal tract, and 3) no ipsilateral corticospinal tract preserved. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional inhibitory rTMS applied to the contralesional primary motor cortex.
- Conditions
- Stroke
- Being tested
- High-Frequency1, cTBS1, High-Frequency2, cTBS2, High-Frequency3
- Keywords
- Stroke, rTMS, Functional reserve
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency1Device
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses.
rTMS target: ipsilateral primary motor cortex.
Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.
Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
cTBS1Device
rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses.
rTMS target: contralateral primary motor cortex.
Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.
Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
High-Frequency2Device
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses.
rTMS target: ipsilateral premotor cortex.
Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.
Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
cTBS2Device
rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses.
rTMS target: contralateral primary motor cortex.
Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.
Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
High-Frequency3Device
rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses.
rTMS target: contralateral primary motor cortex.
Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.
Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
cTBS3Device
rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses.
rTMS target: contralateral primary motor cortex.
Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions.
Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
| Study group | Role | What they receive |
|---|---|---|
| High-Frequency1 | Experimental | Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract.
High-frequency rTMS over ipsilateral primary motor cortex will be applied. Receives: Device: High-Frequency1 |
| cTBS1 | Active comparator | Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied. Receives: Device: cTBS1 |
| High-Frequency2 | Experimental | Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract.
High-frequency rTMS over ipsilateral premotor cortex will be applied. Receives: Device: High-Frequency2 |
| cTBS2 | Active comparator | Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied. Receives: Device: cTBS2 |
| High-Frequency3 | Experimental | Absent responses in all ipsilateral corticospinal tract.
High-frequency rTMS over contralateral primary motor cortex will be applied. Receives: Device: High-Frequency3 |
| cTBS3 | Active comparator | Absent responses in all ipsilateral corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied. Receives: Device: cTBS3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Secondary outcomes (23)
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Fugl-Meyer Assessment score (FMA)
Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Fugl-Meyer Assessment score (FMA)
Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Fugl-Meyer Assessment score (FMA)
Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
Measurement for motor function of lower limb. Minimum:0, Maximum: 34. Higher score means a better
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Box and block test
Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Box and block test
Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Box and block test
Measurement for gross manual dexterity. Scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds.
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Functional Ambulation Category (FAC)
Measurement for gait function. Minimum: 0, Maximum: 5 Higher score means a better.
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Functional Ambulation Category (FAC)
Measurement for gait function. Minimum: 0, Maximum: 5 Higher score means a better.
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Functional Ambulation Category (FAC)
Measurement for gait function. Minimum: 0, Maximum: 5. Higher score means a better.
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Action Research Arm Test (ARAT)
Measurement to assess upper extremity performance (coordination, dexterity and functioning).
Minimum: 0, Maximum: 57. Higher score means a better.
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Action Research Arm Test (ARAT)
Measurement to assess upper extremity performance (coordination, dexterity and functioning).
Minimum: 0, Maximum: 57. Higher score means a better.
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Action Research Arm Test (ARAT)
Measurement to assess upper extremity performance (coordination, dexterity and functioning).
Minimum: 0, Maximum: 57. Higher score means a better.
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Jebsen-Taylor hand function test
Measurement of fine and gross motor hand function using simulated activities of daily living.
Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Jebsen-Taylor hand function test
Measurement of fine and gross motor hand function using simulated activities of daily living.
Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Jebsen-Taylor hand function test
Measurement of fine and gross motor hand function using simulated activities of daily living.
Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.
Measured: From baseline T0 to Follow-up T3 (2 months)
Differences of Hand grip strength test
Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.
Measured: From baseline T0 to During-intervention T1 (1 week)
Differences of Hand grip strength test
Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.
Measured: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Hand grip strength test
Measurement of muscular strength or the maximum force generated by forearm muscles, measured by Jamar hydraulic hand dynamometer.
Measured: From baseline T0 to Follow-up T3 (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start13 Feb 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Parallel groups
- Model description
- prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, Ministry of Food and Drug Safety, Korea, Seoul National University Hospital, Bucheon St. Mary's Hospital, Saint Vincent's Hospital, Korea, Severance Hospital, Kumoh National Institute of Technology, NEUROPHET
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
- Investigators
- Won Hyuk Chang, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270238
- Sponsor's protocol ID
- 2023-11-164
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HS, Kim DH, Seo HG, Im S, Yoo YJ, Kim NY, Lee J, Kim D, Park HY, Yoon MJ, Kim YS, Kim H, Chang WH. Efficacy of personalized rTMS to enhance upper limb function in subacute stroke patients: a protocol for a multi-center, randomized controlled study. Front Neurol. 2024 Jul 3;15:1427142. doi: 10.3389/fneur.2024.1427142. eCollection 2024.
PubMed 39022726
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients: A Multi Center, Randomized, Single Blind, Parallel Group Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06270238
- Acronym / sponsor ID
- 2023-11-164
- Conditions
- Stroke
- Keywords
- Stroke, rTMS, Functional reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, Ministry of Food and Drug Safety, Korea, Seoul National University Hospital, Bucheon St. Mary's Hospital, Saint Vincent's Hospital, Korea, Severance Hospital, Kumoh National Institute of Technology, NEUROPHET
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Feb 2024 (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 objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
Detailed description
rTMS treatment for patients with stroke is traditionally based on interhemispheric interactions. The widely-used traditional rTMS treatment protocol involves inhibitory low-frequency or continuous theta burst stimulation (cTBS) applied over the contralesional hemisphere and excitatory high-frequency stimulation over the ipsilesional hemisphere. However, concerns have arisen regarding the effect of rTMS on motor recovery in stroke patients. Although still subject to debate, a possible reason for the diverse results of rTMS applied to stroke patients is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery.
Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each hemiplegic stroke patient.
Based on screening evaluations (TMS-induced motor evoked potential (MEP), diffusion tensor imaging (DTI), MRI), investigators hypothesized that patients could be categorized into three groups: 1) preserved ipsilateral corticospinal tract, 2) preserved ipsilateral alternative corticospinal tract, and 3) no ipsilateral corticospinal tract preserved. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional inhibitory rTMS applied to the contralesional primary motor cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| High-Frequency1 | Experimental | Device: High-Frequency1Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract. High-frequency rTMS over ipsilateral primary motor cortex will be applied. |
| cTBS1 | Active comparator | Device: cTBS1Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied. |
| High-Frequency2 | Experimental | Device: High-Frequency2Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract. High-frequency rTMS over ipsilateral premotor cortex will be applied. |
| cTBS2 | Active comparator | Device: cTBS2Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied. |
| High-Frequency3 | Experimental | Device: High-Frequency3Absent responses in all ipsilateral corticospinal tract. High-frequency rTMS over contralateral primary motor cortex will be applied. |
| cTBS3 | Active comparator | Device: cTBS3Absent responses in all ipsilateral corticospinal tract. continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,
- FMA score of the upper extremity ≤42,
- adequate language and cognitive function to perform at least a 1-step obey-command,
- pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
- aged ≥19 years old,
Key exclusion criteria (7 listed)
- those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
- those with progressive of hemodynamically unstable medical conditions,
- those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
- those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
- those having contraindications to conduct an MRI study,
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 |
|---|---|---|
| High-Frequency1rTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke. | Device | High-Frequency1 |
| cTBS1rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke. | Device | cTBS1 |
| High-Frequency2rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral premotor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke. | Device | High-Frequency2 |
| cTBS2rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke. | Device | cTBS2 |
| High-Frequency3rTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke. | Device | High-Frequency3 |
| cTBS3rTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke. | Device | cTBS3 |
Primary outcome
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
23 secondary outcomes
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Fugl-Meyer Assessment score (FMA)
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Fugl-Meyer Assessment score (FMA)
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Fugl-Meyer Assessment score (FMA)
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Box and block test
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Box and block test
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Box and block test
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Functional Ambulation Category (FAC)
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Functional Ambulation Category (FAC)
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Functional Ambulation Category (FAC)
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Action Research Arm Test (ARAT)
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Action Research Arm Test (ARAT)
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Action Research Arm Test (ARAT)
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Jebsen-Taylor hand function test
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Jebsen-Taylor hand function test
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Jebsen-Taylor hand function test
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Hand grip strength test
Time frame: From baseline T0 to During-intervention T1 (1 week)
Differences of Hand grip strength test
Time frame: From baseline T0 to Post-intervention T2 (2 weeks)
Differences of Hand grip strength test
Time frame: From baseline T0 to Follow-up T3 (2 months)
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 24 Apr 2026.
- Derived from this study: PubMed 39022726Lee HS, Kim DH, Seo HG, Im S, Yoo YJ, Kim NY, Lee J, Kim D, Park HY, Yoon MJ, Kim YS, Kim H, Chang WH. Efficacy of personalized rTMS to enhance upper limb function in subacute stroke patients: a protocol for a multi-center, randomized controlled study. Front Neurol. 2024 Jul 3;15:1427142. doi: 10.3389/fneur.2024.1427142. eCollection 2024.
- Individual participant dataSharing planned: No
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Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Won Hyuk Chang, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency1, cTBS1 and High-Frequency2 in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 South Korea. 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 Won Hyuk Chang, PhD (82-2-3410-6068, wh.chang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) (time frame: From baseline T0 to Post-intervention T2 (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270238, which also lists 1 linked publication.
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 24 Apr 2026.