Near Infrared Spectroscopy in Children With Autism and ADHD

Terminated

• Conditions: Attention Deficit Disorder With Hyperactivity; Autism; Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorders

• Registration Number: NCT01730079
• Lead Sponsor: National Institute of Mental Health (NIMH)

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:

* To see how well NIRS can detect changes in brain blood flow during tests of thinking and memory in children.

* To compare blood flow in the brains of typically developing children and those with ADHD or ASD.

Eligibility:

- Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric diagnoses.

Design:

* Participants will be screened for eligibility. Those who are taking stimulant medication for ADHD or ASD will need to stop taking it for 3 days before the study visit.

* After participating in a screening assessment, all participants will have one study visit. At this visit, they will have be asked to complete two tasks during a NIRS scan. For both tasks, they will react to images on a computer screen. This visit will last about 2 hours.

* This is a testing study only. No blood or other samples will be needed for this study.

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.

Study Timeline

• Study Start: 2012-10-23
• Study First Submitted: 2012-11-17
• Study First Submitted QC: 2012-11-17
• Study First Posted: 2012-11-21
• Status Verified: 2017-04-11
• Primary Completion: 2017-04-11
• Study Completion: 2017-04-11
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.

Secondary Outcome Measures

Name	Time	Method
Differential activity according to region of the frontal cortext and task elements.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States