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NCT00449566 Clinical Trial

Magnetic Resonance Imaging of Brain Development in Autism

Autism Clinical Trial

Official title:
Magnetic Resonance Imaging of Brain Development in Autism

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00449566
Other study ID # METC 05/208-K
Secondary ID
Status Recruiting
Phase N/A
First received March 18, 2007
Last updated March 18, 2007
Start date January 2006

Study information
Verified date March 2007
Source UMC Utrecht
Contact Sarah Durston
Phone +31 30 250 8161
Email S.Durston@umcutrecht.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

1. Aged 6 - 18 years at initial MRI

Inclusion criteria for subjects with autism

1) DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview

Inclusion criteria for controls

1. no DSM-IV (APA, 1994) diagnosis, according to DISC interview

2. no scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)

3. IQ > 70

Exclusion Criteria:

1. major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system

2. presence of metal objects in or around the body (pacemaker, dental braces)

3. history of or present neurological disorder

4. 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

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Dept. of Child and Adolescent Psychiatry, UMC Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. Epub 2007 Jan 16. — View Citation

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