- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00382382
Diffusion Tensor Imaging in Autism
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32611
- McKnight Brain Institute of the University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Children with Autism
A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in high functioning austistic children.
|
Both groups will have a diffusion tensor imaging (DTI) perform.
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Other: Healthy Volunteers
A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in healthy volunteers.
|
Both groups will have a diffusion tensor imaging (DTI) perform.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
RBS-R scores, including both total and subset scores
Time Frame: once
|
once
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mark H. Lewis, PhD, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R03HD051656 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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