Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-31 @ 1:29 AM
Study NCT ID:
NCT00449566
Status:
UNKNOWN
Last Update Posted:
2007-03-20
First Post:
2007-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging of Brain Development in Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-03-18', 'studyFirstSubmitDate': '2007-03-18', 'studyFirstSubmitQcDate': '2007-03-18', 'lastUpdatePostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging', 'Diffusion Tensor Imaging'], 'conditions': ['Autism']}, 'referencesModule': {'references': [{'pmid': '17224135', 'type': 'BACKGROUND', 'citation': 'Langen M, Durston S, Staal WG, Palmen SJ, van Engeland H. Caudate nucleus is enlarged in high-functioning medication-naive subjects with autism. Biol Psychiatry. 2007 Aug 1;62(3):262-6. doi: 10.1016/j.biopsych.2006.09.040. Epub 2007 Jan 16.'}], 'seeAlsoLinks': [{'url': 'http://www.niche-lab.nl', 'label': 'Lab homepage with info for subjects (in Dutch)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate brain development in autism by longitudinally assessing children with autism, as well as typically developing controls, using advanced MR techniques. We will use longitudinal diffusion tensor imaging (DTI) measures to investigate the protracted development of long-range white matter fibers in autism. In addition, we will investigate the effect of autism risk genes on brain development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 6 - 18 years at initial MRI\n\nInclusion criteria for subjects with autism\n\n1\\) DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview\n\nInclusion criteria for controls\n\n1. no DSM-IV (APA, 1994) diagnosis, according to DISC interview\n2. no scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)\n3. IQ \\> 70\n\nExclusion Criteria:\n\n1. major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system\n2. presence of metal objects in or around the body (pacemaker, dental braces)\n3. history of or present neurological disorder\n4. for individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based'}, 'identificationModule': {'nctId': 'NCT00449566', 'briefTitle': 'Magnetic Resonance Imaging of Brain Development in Autism', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Magnetic Resonance Imaging of Brain Development in Autism', 'orgStudyIdInfo': {'id': 'METC 05/208-K'}}, 'contactsLocationsModule': {'locations': [{'zip': '3584CX', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marieke Langen, M.Sc.', 'role': 'CONTACT', 'email': 'M.Langen@umcutrecht.nl', 'phone': '+31 30 250 7084'}, {'name': 'Marieke Langen, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hilde Nederveen, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Child and Adolescent Psychiatry, UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Sarah Durston', 'role': 'CONTACT', 'email': 'S.Durston@umcutrecht.nl', 'phone': '+31 30 250 8161'}], 'overallOfficials': [{'name': 'Sarah Durston, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht'}, {'name': 'Herman van Engeland, M.D. Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Rudolf Magnust Institute of Neuroscience, UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}}}}