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| Name | Class |
|---|---|
| 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 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Frequency1 | Experimental | Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract. High-frequency rTMS over ipsilateral primary motor cortex will be applied. |
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| 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. |
|
| 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. |
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| 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. |
|
| High-Frequency3 | Experimental | Absent responses in all ipsilateral corticospinal tract. High-frequency rTMS over contralateral primary motor cortex will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Frequency1 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline T0 to Post-intervention T2 (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline T0 to During-intervention T1 (1 week) |
| Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won Hyuk Chang, PhD | Contact | 82-2-3410-6068 | wh.chang@samsung.com | |
| Ho Seok Lee, PhD | Contact | 82-2-3410-2810 | hoseok89.lee@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Won Hyuk Chang, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39022726 | Derived | 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. |
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| OTHER |
| Saint Vincent's Hospital, Korea | OTHER |
| Severance Hospital | OTHER |
| Kumoh National Institute of Technology | UNKNOWN |
| NEUROPHET | INDUSTRY |
prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
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The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis.
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| 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. |
|
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| cTBS1 | Device | 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 | Device | 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 | Device | 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 | Device | 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 | Device | 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. |
|
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better |
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline T0 to Follow-up T3 (2 months) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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