Cognitive Neuroscience of Autism Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT01031407|
Recruitment Status : Recruiting
First Posted : December 14, 2009
Last Update Posted : September 25, 2019
|First Submitted Date||December 11, 2009|
|First Posted Date||December 14, 2009|
|Last Update Posted Date||September 25, 2019|
|Actual Study Start Date||February 21, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Group differences in brain structure, brain function, and cognitive functions, as well as their genetic associations.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01031407 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Cognitive Neuroscience of Autism Spectrum Disorders|
|Official Title||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.
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.
Outcome Measures: Behavioral (reaction time, accuracy, eye movements, etc.) and neuroimaging (brain morphometry, BOLD, electrophysiology, etc.).
|Study Design||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Subjects will include:
Subjects in the ASD group will:
For inclusion in the facial recognition substudy, subjects must be:
All subjects, except for savants, also will be excluded if they have:
Healthy volunteers, except for parents of individuals with autism spectrum disorders and parents of healthy volunteers, 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 because: 1) they are a very rare group, thus we don t want to limit recruitment further and 2) we can examine common and unique cognitive mechanisms across savants, a question of keen interest, regardless of co-morbidities. Those with tumors or other neuroimaging-relevant contraindications will be excluded from fMRI/MEG procedures.
|Ages||5 Years to 89 Years (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100027
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )|
|Study Sponsor||National Institute of Mental Health (NIMH)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 20, 2019|