protocolSection identificationModule nctId: NCT06350617, orgStudyIdInfo id: 2023-12-028, briefTitle: Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, 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 patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease 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 patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves., conditionsModule conditions: Parkinson's Disease and Parkinsonism, 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: 60, type: ESTIMATED, armsInterventionsModule interventions name: High-Frequency, ipsilateral M1, interventions name: High-Frequency, bilateral M1, interventions name: High-Frequency, Lt. DLPFC, interventions name: High-Frequency, bilateral M1, outcomesModule primaryOutcomes measure: Differences of Timed Up and Go Test (TUG), secondaryOutcomes measure: Differences of Timed Up and Go Test (TUG), secondaryOutcomes measure: Differences of Timed Up and Go Test (TUG), secondaryOutcomes measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog), secondaryOutcomes measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog), secondaryOutcomes measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog), secondaryOutcomes measure: Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III, secondaryOutcomes measure: Differences of MDS-UPDRS, Part III, secondaryOutcomes measure: Differences of New Freezing of Gait Questionnaire (FoG-Q), secondaryOutcomes measure: Differences of New Freezing of Gait Questionnaire (FoG-Q), secondaryOutcomes measure: Differences of Digit span Test, secondaryOutcomes measure: Differences of Digit span Test, secondaryOutcomes measure: Differences of Trail making Test, secondaryOutcomes measure: Differences of Trail making Test, secondaryOutcomes measure: Differences of Gait lab parameter (Gait speed), secondaryOutcomes measure: Differences of Gait lab parameter (Gait speed), secondaryOutcomes measure: Differences of Gait lab parameter (Stride length), secondaryOutcomes measure: Differences of Gait lab parameter (Stride length), secondaryOutcomes measure: Differences of Gait lab parameter (Step count), secondaryOutcomes measure: Differences of Gait lab parameter (Step count), secondaryOutcomes measure: Differences of Gait lab parameter (Cadence), secondaryOutcomes measure: Differences of Gait lab parameter (Cadence), secondaryOutcomes measure: Differences of Gait lab parameter (Swing ratio), secondaryOutcomes measure: Differences of Gait lab parameter (Swing ratio), secondaryOutcomes measure: Differences of Gait lab parameter (Stride time), secondaryOutcomes measure: Differences of Gait lab parameter (Stride time), secondaryOutcomes measure: Differences of Gait lab parameter (Pressure distribution), secondaryOutcomes measure: Differences of Gait lab parameter (Pressure distribution), eligibilityModule sex: ALL, minimumAge: 50 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