Cognitive Neuroscience of Autism Spectrum Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01031407|
Recruitment Status : Recruiting
First Posted : December 14, 2009
Last Update Posted : March 29, 2018
|First Submitted Date||December 11, 2009|
|First Posted Date||December 14, 2009|
|Last Update Posted Date||March 29, 2018|
|Study Start Date||November 19, 2009|
|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 Outcome Measures||Not Provided|
|Original Other 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:
Inclusion criteria for cognitively impaired children without ASD, Subjects will include:
Subjects in the ASD group will:
All subjects, except for savants, also will be excluded if they have:
Exclusion criteria for cognitively impaired children:
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 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, Senior)|
|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||March 14, 2018|