Cognitive Neuroscience of Autism Spectrum Disorders
|First Received Date ICMJE||December 11, 2009|
|Last Updated Date||June 5, 2013|
|Start Date ICMJE||November 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Group differences in brain structure, brain function, and cognitive functions, as well as their genetic associations.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01031407 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Cognitive Neuroscience of Autism Spectrum Disorders|
|Official Title ICMJE||Cognitive Neuroscience of Autism Spectrum Disorders|
The following groups of participants will be eligible for the study:
Objective: The primary objective of the proposed studies is to utilize neuroimaging (functional Magnetic Resonance Imaging [fMRI], structural MRI [sMRI], Magnetoencephalography [MEG]) and neuropsychological tools (eye-tracking, cognitive experiments, clinical neuropsychological measures, questionnaires, etc.) to identify cognitive idiosyncrasies (e.g., social-cognitive deficits, visual perceptual assets, and savant skills) characteristic of individuals on the autism spectrum and their neural underpinnings across childhood and adulthood. A secondary aim is to utilize the phenotypic data collected from these studies (and previous data collection) to identify subtypes that may inform genetic studies (both candidate gene and genome-wide scans) by linking these phenotypic data with genetic data.
Study Population: Children, adolescents, and adults with autism spectrum disorders (ASDs), controls (i.e., typically developing children, adolescents, and adults and those with mild to moderate mental retardation), as well as caregivers/legal guardians/parents of these individuals.
Design: Descriptive/Characterization/Observational studies using primarily neuropsychological and neuroimaging methodologies as well as genetic techniques.
Outcome Measures: Behavioral (reaction time, accuracy, eye movements, etc.) and neuroimaging (brain morphometry, BOLD, electrophysiology, etc.).
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1400|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects will include:
Subjects in the ASD group will:
All subjects, except for savants, also will be excluded if they have:
Healthy volunteers, except for parents of individuals with autism spectrum disorders, parents of healthy volunteers, and parents of children with cognitive impairments, will also be excluded if they have:
1. a current or past history of axis I psychiatric conditions or any current usage of psychiatric medication.
Savants have less restrictive exclusionary criteria. Those with tumors or other neuroimaging-relevant contraindications will be excluded from fMRI/MEG procedures.
|Ages||5 Years to 89 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01031407|
|Other Study ID Numbers ICMJE||100027, 10-M-0027|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP