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Diffusion Tensor Imaging in Autism

Primary Purpose

Autistic Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diffusion tensor imaging (DTI)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autistic Disorder focused on measuring Autism, Asperger Syndrome, Restricted repetitive behavior, Stereotyped patterns of behavior, Typically Developing children, Human Volunteers

Eligibility Criteria

8 Years - 12 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • McKnight Brain Institute of the University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Children with Autism

Healthy Volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

RBS-R scores, including both total and subset scores

Secondary Outcome Measures

Full Information

First Posted
September 28, 2006
Last Updated
March 12, 2015
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00382382
Brief Title
Diffusion Tensor Imaging in Autism
Official Title
Diffusion Tensor Imaging in Autism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study was completed but there were no participants. It was completed as a theoretical study. Requests for final progress report can be sent to Dr. Liu.
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Using a new and more detailed approach to diffusion tensor imaging (DTI) recently developed in our lab, the investigators aim to confirm and expand upon previous findings of white matter abnormalities throughout the brain in individuals with autism. The investigators have chosen to focus particularly on cerebellar and motor pathways in consideration of the prevalence of motor deficits in autism as well as brain structural studies that have indicated cerebellar abnormalities in autistic children. Finally, a proposal to investigate a possible functional association between white matter structure and the expression of restricted repetitive behaviors in autistic children, by correlating measures of white matter integrity with behavioral assessments indicating the severity of various forms of restricted repetitive behaviors. Two specific aims will be accomplished. Aim 1: To examine the integrity of white matter pathways in high functioning autistic children. The hypothesis is that autism is associated with specific white matter abnormalities in the cerebellum and other motor circuits. Additionally, it is 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 hypothesis is 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, Asperger Syndrome, Restricted repetitive behavior, Stereotyped patterns of behavior, Typically Developing children, Human Volunteers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with Autism
Arm Type
Other
Arm Description
A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in high functioning austistic children.
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in healthy volunteers.
Intervention Type
Other
Intervention Name(s)
diffusion tensor imaging (DTI)
Intervention Description
Both groups will have a diffusion tensor imaging (DTI) perform.
Primary Outcome Measure Information:
Title
RBS-R scores, including both total and subset scores
Time Frame
once

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark H. Lewis, PhD
Organizational Affiliation
University of Florida
Official's Role
Study Director
Facility Information:
Facility Name
McKnight Brain Institute of the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

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Diffusion Tensor Imaging in Autism

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