Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-30 @ 10:25 PM
Study NCT ID:
NCT04055857
Status:
UNKNOWN
Last Update Posted:
2019-08-14
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease(NIID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537395', 'term': 'Neuronal intranuclear inclusion disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-11', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-08-11', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fractional anisotropy (FA)', 'timeFrame': 'baseline', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'mean diffusivity (MD)', 'timeFrame': 'baseline', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'Intracellular volume fraction(icvf)', 'timeFrame': 'baseline', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'orientation dispersion index (ODI)', 'timeFrame': 'baseline', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'fiber number(fiber pass through the lesions)', 'timeFrame': 'baseline', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'fractional anisotropy (FA)', 'timeFrame': '6 months', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'mean diffusivity (MD)', 'timeFrame': '6 months', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'Intracellular volume fraction(icvf)', 'timeFrame': '6 months', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'orientation dispersion index (ODI)', 'timeFrame': '6 months', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'fiber number(fiber pass through the lesions)', 'timeFrame': '6 months', 'description': 'Parameters to describe integrity of white matter in diffusion MR Imaging'}, {'measure': 'short-range and long-range functional connectivity around the lesions at rest', 'timeFrame': 'baseline', 'description': 'Functional network connectivity impairments in patients'}, {'measure': 'short-range and long-range functional connectivity around the lesions at rest', 'timeFrame': '6 months', 'description': 'Functional network connectivity impairments in patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuronal Intranuclear Inclusion Disease']}, 'descriptionModule': {'briefSummary': 'To discover the microstructure, macrostructure and functional changes with 7T multi-modal magnetic resonance imaging of Neuronal Intranuclear Inclusion Disease, and to explore new biomarkers for evaluating the severity and the progression of Neuronal Intranuclear Inclusion Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects enrolled in the study shall be selected from NIID patients who are diagnosed with skin biopsy and gene detection. The Investigator is responsible for screening potential subjects and selecting those who meet the eligibility criteria for the study as described.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with NIID\n2. Older than 18 years;\n3. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. The informed consent is withdrawn by the subject;\n2. Contraindications or intolerance to MRI: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.'}, 'identificationModule': {'nctId': 'NCT04055857', 'briefTitle': 'Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease(NIID)', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease: A Pioneer Multi-modal 7T MRI Observational Study.', 'orgStudyIdInfo': {'id': '7TMRINIID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NIID', 'description': 'NIID patients'}, {'label': 'HC', 'description': 'healthy control'}], 'interventions': [{'type': 'OTHER', 'description': 'There is no Intervention.', 'armGroupLabels': ['HC', 'NIID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Xiong', 'role': 'CONTACT'}], 'facility': 'Siemens 7T MR', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Hui Liang, Doctor', 'role': 'CONTACT', 'email': 'pushup@zju.edu.cn', 'phone': '18757139736', 'phoneExt': '+86'}, {'name': 'Daqiang Ke, Bachelor', 'role': 'CONTACT', 'email': 'zhemuzhi@163.com', 'phone': '15658173819', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Ruiliang Bai, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University Interdisciplinary Institute of Neuroscience and Technology (ZIINT)'}, {'name': 'Hui Liang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University Interdisciplinary Institute of Neuroscience and Technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}