Near Infrared Spectroscopy in Children With Autism and ADHD
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| First Received Date ICMJE | November 17, 2012 | ||||||||
| Last Updated Date | May 1, 2013 | ||||||||
| Start Date ICMJE | October 2012 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks. | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01730079 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Differential activity according to region of the frontal cortext and task elements. | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Near Infrared Spectroscopy in Children With Autism and ADHD | ||||||||
| Official Title ICMJE | Near Infra-Red Spectroscopy (NIRS) in Neurodevelopmental Disorders and Typically Developing Children | ||||||||
| Brief Summary | Background: - Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light to study brain function while allowing for movement. To look at blood flow in the brain, NIRS uses a low-power light source with detectors that see how the light changes as it passes through brain tissue. Brain blood flow can indicate which parts of the brain are active during different tasks. Researchers want to study children with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to compare the blood flow in the brain of children with ADHD and ASD with that of typically developing children. Objectives:
Eligibility: - Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric diagnoses. Design:
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| Detailed Description | Objective: to test whether Near Infra-Red Spectroscopy (NIRS) can be used to monitor cognitive brain function and detect markers for differentiation of Autism Spectrum Disorders (ASD) and Attention Deficit Hyperactivity Disorder (ADHD). Study population: Children with ASD, ADHD, and typically developing children, all between 4 and 8 years of age. Design: The study will investigate NIRS signal changes while children with ASD, ADHD, and typically developing children perform well-known functional tasks. Outcome Measures: Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Children will be between 4 to 8 years of age (4 years, 0 months to 8 years, 11 months). English speakers only will be recruited for the study, because the language measures/tests and stimuli being used are in English and were developed and standardized on English-only samples. Typically Developing Group: -Development in nonverbal and verbal areas within age expectations (per scores onthe Differential Ability Scales, Second Edition or the Wechsler Preschool and Primary Scale of Intelligence(Trademark) - Fourth Edition , no more than 1.5 standard deviation below the mean) ASD Group:
ADHD Group: -Diagnosis of ADHD based on diagnostic evaluation conducted through a separate screening protocol Minimum Nonverbal IQ of 80; Minimum Verbal IQ score of 60 EXCLUSION CRITERIA: All children who meet the following criteria:
Typically Developing Group:
ASD Group:
ADHD Group:
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| Gender | Both | ||||||||
| Ages | 4 Years to 8 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01730079 | ||||||||
| Other Study ID Numbers ICMJE | 130007, 13-M-0007 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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