Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 5:18 PM
Study NCT ID:
NCT06316557
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter Randomized Double-Blind Controlled Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of improving cognitive function of post-stroke cognitive impairment', 'timeFrame': '3 months follow-up after treatment', 'description': 'The change of MoCA between baseline and 3 months follow-up'}], 'secondaryOutcomes': [{'measure': 'The safety of improving cognitive function of post-stroke cognitive impairment', 'timeFrame': 'day1-day7', 'description': 'Incidence of epilepsy during treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-stroke Cognitive Impairment', 'Repetitive transcranial magnetic stimulation', 'High-frequency', 'Cerebellar'], 'conditions': ['Post-stroke Cognitive Impairment', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.', 'detailedDescription': 'The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion criteria:\n\n(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA\\<26;\n\nKey exclusion criteria:\n\n(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;'}, 'identificationModule': {'nctId': 'NCT06316557', 'acronym': 'HOPE', 'briefTitle': 'HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke', 'orgStudyIdInfo': {'id': 'HX-A-2022063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iTBS group', 'description': 'iTBS on the contralesional cerebellum', 'interventionNames': ['Device: iTBS group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'shame stimulation on the contralesional cerebellum', 'interventionNames': ['Device: control group']}], 'interventions': [{'name': 'iTBS group', 'type': 'DEVICE', 'description': 'iTBS on the contralesional cerebellum, twice a day for seven days', 'armGroupLabels': ['iTBS group']}, {'name': 'control group', 'type': 'DEVICE', 'description': 'shame stimulation on the contralesional cerebellum, twice a day for seven days', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weili Jia', 'role': 'CONTACT', 'email': 'jiawl1994@163.com', 'phone': '+86 13120207987'}, {'name': 'Zixiao Li, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Weili Jia, Dr.', 'role': 'CONTACT', 'email': 'jiawl1994@163.com', 'phone': '+86 13120207987'}], 'overallOfficials': [{'name': 'Zixiao LI, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zi-Xiao Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Zi-Xiao Li', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}