MR Scanning of Very Young Children With Severe Developmental Disorders

Autism Clinical Trial

Official title:

MR Scanning of Very Young Children With Severe Developmental Disorders (Autistic Spectrum Disorders and/or Mental Retardation and/or Language Disorders)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156221
• Other study ID #: METC UMC Utrecht 99/184
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: September 8, 2005
• Start date: September 2000
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

The specific is to study the MR morphologic and spectroscopic brain correlates and predictors of development in children with severe developmental disorders (autistic spectrum disorders and/or mental retardation and/or language disorders). Given the frequently observed association of autism with known medical conditions, particularly in cases with comorbid mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995), children with suspected autism or related developmental disorders will be asked to participate in an extensive state of the art laboratory work-up which includes T1 and T2 weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal abnormalities and degree of myelination, and quantitatively, measuring volumes of total brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data set provides the opportunity to chart brain-behavior relationships in young children with suspected autism and related PDD cross-sectionally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 7 Years

Eligibility

Inclusion Criteria:

• Age 18 months to 7 years

• Diagnosis of autism spectrum disorder, a language disorder or mental retardation

Exclusion Criteria:

• Significant motor or sensory impairment

• Major physical abnormalities

• History of serious head injury

• Identifiable neurologic disorder

• Metal implants

• Contraindication for MRI

Study Design

Observational Model: Natural History, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Autism
• Developmental Disabilities
• Disease
• Intellectual Disability
• Language Disorder
• Language Disorders
• Mental Retardation

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Netherlands Organisation for Scientific Research, The Dutch Brain Foundation

Country where clinical trial is conducted

Netherlands,