nctId: NCT06270238 id: 2023-11-164 briefTitle: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients overallStatus: RECRUITING date: 2024-02-13 date: 2025-09-30 date: 2025-09-30 date: 2024-02-21 date: 2024-02-29 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: 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. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: 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. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: High-Frequency1 name: cTBS1 name: High-Frequency2 name: cTBS2 name: High-Frequency3 name: cTBS3 measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: wh.chang@samsung.com lat: 37.566 lon: 126.9784 hasResults: False