Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 10:39 PM
Study NCT ID:
NCT06041659
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009072', 'term': 'Moyamoya Disease'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of brain functional network', 'timeFrame': 'Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min'}], 'secondaryOutcomes': [{'measure': 'Postoperative delirium', 'timeFrame': 'Day1-5 after surgery'}, {'measure': 'Electroencephalogram changes', 'timeFrame': 'Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moyamoya Disease', 'Cerebral Network', 'Cognitive Function', 'Anesthesia'], 'conditions': ['Moyamoya Disease']}, 'descriptionModule': {'briefSummary': 'Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We plan to recruit consecutive patients with moyamoya disease who are to undergo direct or indirect revascularization surgery from August 2023 to December 2025 at Beijing Tiantan Hospital of Capital Medical University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery\n* Age between 18-65 years\n* Obtain written informed consent.\n\nExclusion Criteria:\n\n* Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination\n* Preoperative cranial imaging suggesting cerebral infarction lesion diameter \\>15mm\n* Patients allergic to anesthetic drugs\n* Metal implants in the body\n* Undergoing other experimental drug or instrumentation trials'}, 'identificationModule': {'nctId': 'NCT06041659', 'briefTitle': 'Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Functional Magnetic Resonance-Based Observations of Brain Networks and Cerebrovascular Reactivity in Patients With Moyamoya Disease Under Anesthetic Sedation, A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '2023022'}}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shu Li, M.D.', 'role': 'CONTACT', 'email': 'lishu@bjtth.org', 'phone': '13699223065'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shu Li', 'role': 'CONTACT', 'email': 'lishu@bjtth.org', 'phone': '8613699223065'}], 'overallOfficials': [{'name': 'Shu Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yuming Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}