NCT00382382

Brief Summary

Using a new and more detailed approach to diffusion tensor imaging (DTI) recently developed in our lab, the investigators hope to learn more about irregularities in the brain that are related to autism. The investigators are especially interested in brain regions that contribute to repetitive behaviors in children with autism. Repetitive behaviors include stereotyped motor movements (hand-flapping), self-injurious behaviors (head hitting), compulsions (lining up toys), insistence on things staying the same, and difficulty with change. These behaviors often interfere with learning, can disrupt daily functioning, and can lead to other behavioral problems. Two specific aims will be accomplished: Aim 1: To examine the integrity of white matter pathways in high functioning autistic children. The investigators hypothesize that autism is associated with specific white matter abnormalities in the cerebellum and other motor circuits. Additionally, the investigators expect to confirm and expand on previous reports of cerebral abnormalities by using newly developed DTI methods. Aim 2: To determine whether there is a relationship between white matter abnormalities and the occurrence of restricted repetitive behaviors in children with autism. The investigators hypothesize that differences in the occurrence and type of restricted repetitive behaviors between autistic individuals are correlated with specific regional white matter abnormalities. Results from the proposed experiments should contribute to current knowledge of brain abnormalities in autism and their relationship to restricted repetitive behaviors, and may be relevant to understanding the mechanisms underlying motor deficits in this disorder.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

September 28, 2006

Last Update Submit

March 12, 2015

Conditions

Keywords

AutismAsperger SyndromeRestricted repetitive behaviorStereotyped patterns of behaviorTypically Developing childrenHuman Volunteers

Outcome Measures

Primary Outcomes (1)

  • RBS-R scores, including both total and subset scores

    once

Study Arms (2)

Children with Autism

OTHER

A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in high functioning austistic children.

Other: diffusion tensor imaging (DTI)

Healthy Volunteers

OTHER

A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in healthy volunteers.

Other: diffusion tensor imaging (DTI)

Interventions

Both groups will have a diffusion tensor imaging (DTI) perform.

Children with AutismHealthy Volunteers

Eligibility Criteria

Age8 Years - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • male, aged 8-12 years of age
  • clinical diagnoses of autism from a licensed professional for Autism or Asperger's Syndrome
  • IQ \>80
  • no speech delay
  • no major sensory or motor deficits

You may not qualify if:

  • known genetic or medical conditions (e.g. Fragile X syndrome, tuberous sclerosis, Turner's syndrome)
  • currently (within prior 3 months) taking anti-psychotic/dopamine-modulating medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McKnight Brain Institute of the University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Autistic DisorderAsperger Syndrome

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Mark H. Lewis, PhD

    University of Florida

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations