NCT00156221

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Keywords

AutismMRIDevelopmental Disorders

Eligibility Criteria

Age18 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 18 months to 7 years
  • Diagnosis of autism spectrum disorder, a language disorder or mental retardation

You may not qualify if:

  • Significant motor or sensory impairment
  • Major physical abnormalities
  • History of serious head injury
  • Identifiable neurologic disorder
  • Metal implants
  • Contraindication for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Autistic DisorderIntellectual DisabilityLanguage DisordersDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication Disorders

Study Officials

  • Herman van Engeland, PhD, MD

    UMC Utrecht

    STUDY CHAIR
  • Mijke Zeegers, Msc

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2000

Study Completion

September 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations