Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients
NCT ID: NCT06270238
Last Updated: 2024-02-29
Study Results
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Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-02-13
2025-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High-Frequency1
Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract.
High-frequency rTMS over ipsilateral primary motor cortex will be applied.
High-Frequency1
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.
cTBS1
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.
cTBS1
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-Frequency2
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.
High-Frequency2
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.
cTBS2
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.
cTBS2
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-Frequency3
Absent responses in all ipsilateral corticospinal tract.
High-frequency rTMS over contralateral primary motor cortex will be applied.
High-Frequency3
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.
cTBS3
Absent responses in all ipsilateral corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.
cTBS3
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.
Interventions
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High-Frequency1
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.
cTBS1
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-Frequency2
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.
cTBS2
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-Frequency3
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.
cTBS3
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.
Eligibility Criteria
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Inclusion Criteria
2. FMA score of the upper extremity ≤42,
3. adequate language and cognitive function to perform at least a 1-step obey-command,
4. pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
5. aged ≥19 years old,
6. patients willing to sign the informed consent.
Exclusion Criteria
2. those with progressive of hemodynamically unstable medical conditions,
3. those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
4. those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
5. those having contraindications to conduct an MRI study,
6. those who are pregnant or lactating ,
7. patients who have refused to participate in this study.
19 Years
ALL
No
Sponsors
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National Research Foundation of Korea
OTHER
Ministry of Food and Drug Safety, Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Bucheon St. Mary's Hospital
OTHER
Saint Vincent's Hospital, Korea
OTHER
Severance Hospital
OTHER
Kumoh National Institute of Technology
UNKNOWN
NEUROPHET
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
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Won Hyuk Chang
Professor
Principal Investigators
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Won Hyuk Chang, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2023-11-164
Identifier Type: -
Identifier Source: org_study_id
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