Autistic DisorderNCT00382382
Diffusion Tensor Imaging in Autism
A study testing diffusion tensor imaging (DTI) in people with Autistic Disorder, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- diffusion tensor imaging (DTI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
McKnight Brain Institute of the University of Florida
Gainesville, Florida, 32611
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Autistic Disorder
- Being tested
- diffusion tensor imaging (DTI)
- Keywords
- Autism, Asperger Syndrome, Restricted repetitive behavior, Stereotyped patterns of behavior, Typically Developing children, Human Volunteers
- Medical subject headings
- Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion tensor imaging (DTI)Other
Both groups will have a diffusion tensor imaging (DTI) perform.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: diffusion tensor imaging (DTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBS-R scores, including both total and subset scores
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJul 2009
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark H. Lewis, PhD, Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382382
- Sponsor's protocol ID
- 1R03HD051656
- Status last verified
- Mar 2015
- First submitted
- 28 Sep 2006
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging in Autism
- ClinicalTrials.gov ID
- NCT00382382
- Acronym / sponsor ID
- 1R03HD051656
- Conditions
- Autistic Disorder
- Keywords
- Autism, Asperger Syndrome, Restricted repetitive behavior, Stereotyped patterns of behavior, Typically Developing children, Human Volunteers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Autism | Other | Other: diffusion tensor imaging (DTI)A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in high functioning austistic children. |
| Healthy Volunteers | Other | Other: diffusion tensor imaging (DTI)A diffusion tensor imaging (DTI) will be done to examine the integrity of the white matter pathways in healthy volunteers. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion tensor imaging (DTI)Both groups will have a diffusion tensor imaging (DTI) perform. | Other | Children with Autism, Healthy Volunteers |
Primary outcome
RBS-R scores, including both total and subset scores
Time frame: once
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark H. Lewis, PhD study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion tensor imaging (DTI) in people with Autistic Disorder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBS-R scores, including both total and subset scores (time frame: once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015; AzTrials last refreshed its copy on 26 Oct 2026.