protocolSection identificationModule nctId: NCT06270238, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: National Research Foundation of Korea, collaborators name: Ministry of Food and Drug Safety, Korea, collaborators name: Seoul National University Hospital, collaborators name: Bucheon St. Mary's Hospital, collaborators name: Saint Vincent's Hospital, Korea, collaborators name: Severance Hospital, collaborators name: Kumoh National Institute of Technology, collaborators name: NEUROPHET, descriptionModule 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., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: High-Frequency1, interventions name: cTBS1, interventions name: High-Frequency2, interventions name: cTBS2, interventions name: High-Frequency3, interventions name: cTBS3, outcomesModule primaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score (FMA), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score (FMA), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score (FMA), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL), secondaryOutcomes measure: Differences of Box and block test, secondaryOutcomes measure: Differences of Box and block test, secondaryOutcomes measure: Differences of Box and block test, secondaryOutcomes measure: Differences of Functional Ambulation Category (FAC), secondaryOutcomes measure: Differences of Functional Ambulation Category (FAC), secondaryOutcomes measure: Differences of Functional Ambulation Category (FAC), secondaryOutcomes measure: Differences of Action Research Arm Test (ARAT), secondaryOutcomes measure: Differences of Action Research Arm Test (ARAT), secondaryOutcomes measure: Differences of Action Research Arm Test (ARAT), secondaryOutcomes measure: Differences of Jebsen-Taylor hand function test, secondaryOutcomes measure: Differences of Jebsen-Taylor hand function test, secondaryOutcomes measure: Differences of Jebsen-Taylor hand function test, secondaryOutcomes measure: Differences of Hand grip strength test, secondaryOutcomes measure: Differences of Hand grip strength test, secondaryOutcomes measure: Differences of Hand grip strength test, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Won Hyuk Chang, PhD, role: CONTACT, phone: +82-2-3410-6068, email: wh.chang@samsung.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False