Magnetic Resonance Imaging of Brain Development in Autism | NCT00449566

Studies
Magnetic Resonance Imaging of Brain Development in Autism

NCT00449566

Sponsor

UMC Utrecht

Status

Unknown status

Last Update Posted

Mar 20, 2007Estimated

Enrollment

300

Phase

Not provided

Conditions

Autism

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 18, 2007

First Submission Date that Met QC Criteria

Mar 18, 2007

First Posted Date

Mar 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2007

Last Update Posted Date

Mar 20, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

no DSM-IV (APA, 1994) diagnosis, according to DISC interview
no scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
IQ > 70

Exclusion Criteria:

major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
presence of metal objects in or around the body (pacemaker, dental braces)
history of or present neurological disorder
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Durston	Contact	+31 30 250 8161		S.Durston@umcutrecht.nl

Overall Officials

Name	Affiliation	Role
Sarah Durston, Ph.D.	Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht	Principal Investigator
Herman van Engeland, M.D. Ph.D.	Rudolf Magnust Institute of Neuroscience, UMC Utrecht	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Child and Adolescent Psychiatry, UMC Utrecht	Recruiting	Utrecht		3584CX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17224135	Background	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.

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders