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Clinical Trials/NCT01730079
NCT01730079
Terminated
Not Applicable

Near Infra-Red Spectroscopy (NIRS) in Neurodevelopmental Disorders and Typically Developing Children

National Institute of Mental Health (NIMH)1 site in 1 country42 target enrollmentOctober 23, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
National Institute of Mental Health (NIMH)
Enrollment
42
Locations
1
Primary Endpoint
Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2012
End Date
April 11, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Differential activity according to region of the frontal cortext and task elements.

Study Sites (1)

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