Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05445505
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2022-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroprotective Effects of iTBS in PD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in UPDRS scores from baseline to post-iTBS in the four intervention groups (UPDRS part3: range 0\\~72, higher score is related to a worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Group differences of Hoehn-Yahr stage', 'timeFrame': '28 weeks', 'description': 'Compare the changes in Hoehn-Yahr stage from baseline to post-iTBS in the four intervention groups (H-Y stage: range 0\\~5, higher score is related to a worse outcome).'}, {'measure': 'Group differences of Berg Balance Scale (BBS) changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in BBS scores from baseline to post-iTBS in the four intervention groups (BBS: range 0\\~56, higher score is related to a better outcome).'}, {'measure': 'Group differences of Hamilton depression scale-17 (HAMD-17) changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in HAMD-17 scores from baseline to post-iTBS in the four intervention groups (HAMD-17: range 0\\~38, higher score is related to a worse outcome).'}, {'measure': 'Group differences of Hamilton Anxiety Scale (HAMA) changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in HAMA scores from baseline to post-iTBS in the four intervention groups (HAMA: range 0\\~64, higher score is related to a worse outcome).'}, {'measure': 'Group differences of Mini-mental State Examination (MMSE) changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in MMSE scores from baseline to post-iTBS in the four intervention groups (MMSE: range 0\\~30, higher score is related to a better outcome).'}, {'measure': 'Group differences of Montreal Cognitive Assessment (MoCA) changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in MoCA scores from baseline to post-iTBS in the four intervention groups (MoCA: range 0\\~30, higher score is related to a better outcome).'}, {'measure': "Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes", 'timeFrame': '28 weeks', 'description': 'Compare the changes in PDQ-39 scores from baseline to post-iTBS in the four intervention groups (PDQ-39: range 0\\~156, higher score is related to a worse outcome).'}, {'measure': "Group differences of 16-item Sniffin' Sticks test (SS-16) changes", 'timeFrame': '28 weeks', 'description': 'Compare the changes in SS-16 scores from baseline to post-iTBS in the four intervention groups (SS-16: range 0\\~16, higher score is related to a better outcome).'}, {'measure': 'Group differences of Wexner changes', 'timeFrame': '28 weeks', 'description': 'Compare the changes in Wexner scores from baseline to post-iTBS in the four intervention groups (Wexner: range 0\\~30, higher score is related to a worse outcome).'}, {'measure': 'Group differences of adverse event', 'timeFrame': '28 weeks', 'description': 'Compare the adverse event in four intervention groups.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroprotection', 'Parkinson Disease', 'Intermittent Theta Burst Stimulation']}, 'descriptionModule': {'briefSummary': "Intermittent theta burst stimulation (iTBS) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. Combining the results of previous studies and our group's previous research, sixty qualified PD patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of iTBS treatment protocol and explore the neuron-protection of iTBS on neuronal loss of PD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).\n* aged \\>20 years and \\<80 years, regardless of gender.\n* 2 ≤ Hoehn-Yahr stage≤ 4.\n* Maintain medication stability during the study period.\n* Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.\n\nExclusion Criteria:\n\n* Patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery.\n* Patients with significant cognitive impairment (MMSE \\< 24) or inability to complete questionnaires independently.\n* Prior treatment with TMS, DBS or SCS.\n* Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.\n* Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.\n* Are currently taking other investigational drugs.\n* Any other condition that the investigator deems unsuitable for participation in this study."}, 'identificationModule': {'nctId': 'NCT05445505', 'briefTitle': 'Neuroprotective Effects of iTBS in PD', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': "Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study", 'orgStudyIdInfo': {'id': '2022043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early-start single iTBS group', 'description': 'The intensive period: 2 weeks The maintenance period: 12 weeks', 'interventionNames': ['Device: intermittent theta burst stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early-start double iTBS group', 'description': 'The intensive period: 2 weeks The maintenance period: 12 weeks', 'interventionNames': ['Device: intermittent theta burst stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Delayed-start single iTBS group', 'description': 'The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks', 'interventionNames': ['Device: intermittent theta burst stimulation', 'Device: sham iTBS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Delayed-start double iTBS group', 'description': 'The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks', 'interventionNames': ['Device: intermittent theta burst stimulation', 'Device: sham iTBS']}], 'interventions': [{'name': 'intermittent theta burst stimulation', 'type': 'DEVICE', 'otherNames': ['iTBS'], 'description': 'iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.', 'armGroupLabels': ['Delayed-start double iTBS group', 'Delayed-start single iTBS group', 'Early-start double iTBS group', 'Early-start single iTBS group']}, {'name': 'sham iTBS', 'type': 'DEVICE', 'description': 'The pseudo-stimulation device looks and sounds the same as the iTBS device', 'armGroupLabels': ['Delayed-start double iTBS group', 'Delayed-start single iTBS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Liu, Professor', 'role': 'CONTACT', 'email': 'jly0520@hotmail.com', 'phone': '64370045', 'phoneExt': '+86-021'}], 'facility': 'Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jun Liu, Professor', 'role': 'CONTACT', 'email': 'jly0520@hotmail.com', 'phone': '64370045', 'phoneExt': '+86-021'}], 'overallOfficials': [{'name': 'Jun Liu, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data (IPD) was available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}