Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT07064967
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-Helium Magnetoencephalography in Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015225', 'term': 'Magnetoencephalography'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D060306', 'term': 'Magnetometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of Neural Oscillation Characteristics in Children with Autism Spectrum Disorder', 'timeFrame': 'Baseline assessment (single time point, within 1 week of enrollment).', 'description': 'The primary outcome will measure group differences in neural oscillation features (e.g., spectral power and spatial distribution) across frequency bands (alpha, beta, gamma) between children with Autism Spectrum Disorder and typically developing children during resting-state and task-based conditions. Quantified using time-frequency analysis of magnetoencephalography data. Statistical analysis will include independent t-tests (or Mann-Whitney U tests for non-normally distributed data) with false discovery rate (FDR) correction, using SPSS version 27.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism Spectrum Disorder', 'Magnetoencephalography'], 'conditions': ['Autism Spectrum Disorder (ASD)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn how brain activity in children with autism spectrum disorder (ASD) differs from typical developing children using magnetoencephalography (MEG).\n\nThe main questions this study aims to answer are:\n\nDo children with ASD show different patterns of neural oscillation compared to typically developing children? Can MEG identify specific brain features that help ASD diagnosis?\n\nParticipants will undergo MEG scan in both resting and tasking state, and their brain activity will be analyzed for characteristic neural oscillations and connectivity patterns.\n\nThis study may help develop better tools for early ASD diagnosis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pediatric patients of Guangzhou Women and Children's Medical Center", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys aged 6 to 12 years;\n* Diagnosis of Autism Spectrum Disorder meeting DSM-5 criteria;\n* Intelligence quotient (IQ) score \\> 70 (assessed via Wechsler Intelligence Scale for Children or other validated cognitive test);\n* Sufficient compliance to participate in MEG experiments.\n\nExclusion Criteria:\n\n* Comorbid neurological disorders, genetic syndromes, or severe developmental disabilities;\n* Metallic implants that may interfere with MEG signal acquisition;\n* Current use of antipsychotic medications or sedatives.'}, 'identificationModule': {'nctId': 'NCT07064967', 'briefTitle': 'Non-Helium Magnetoencephalography in Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Non-Helium Magnetoencephalography for Identifying Neurobiological Features and Functional Biomarkers in Children With Autism Spectrum Disorder: An Observational Cohort Study', 'orgStudyIdInfo': {'id': '447A01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD', 'description': 'Participants in the ASD group consisted of children diagnosed with Autism Spectrum Disorder according to DSM-5 criteria.', 'interventionNames': ['Diagnostic Test: Magnetoencephalography']}, {'label': 'Control', 'description': 'Participants in the Control group consisted of typically developing children.', 'interventionNames': ['Diagnostic Test: Magnetoencephalography']}], 'interventions': [{'name': 'Magnetoencephalography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo magnetoencephalography scan in both resting and tasking state.', 'armGroupLabels': ['ASD', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '511399', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhao Zhou, Medical Doctor', 'role': 'CONTACT', 'email': '15625984282@163.com', 'phone': '+86-020-81886332'}], 'facility': "Guangzhou Women and Children's medical center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ye Song, Medical Doctor', 'role': 'CONTACT', 'email': '15625984282@163.com', 'phone': '+86-020-81886332'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing X-Magtech Technology Limited', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}