Near Infrared Spectroscopy in Children With Autism and ADHD
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Purpose
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.
| Condition |
|---|
|
Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder Attention Deficit Hyperactivity Disorder Autism Autism Spectrum Disorders |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Near Infra-Red Spectroscopy (NIRS) in Neurodevelopmental Disorders and Typically Developing Children |
- Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.
- Differential activity according to region of the frontal cortext and task elements.
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 4 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
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:
- Diagnosis of Autistic Disorder, Asperger's disorder, or Pervasive Developmental Disorder - Not Otherwise Specified (PDD - NOS), based on diagnostic evaluation conducted through a separate screening protocol
- Minimum Nonverbal IQ score of 80; Minimum Verbal IQ score of 60
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:
- Primary language spoken at home is other than English
- Any skin disease that affects the scalp
- Past or present vascular disease, such as lupus, ankylosing spondylitis or scleroderma.
- Known adverse reaction to latex
- Presence or history of medical conditions known to affect cerebral anatomy, such as known cysts, arterivenous malformations or cortical tubers.
- Head trauma with loss of consciousness lasting longer than 5 seconds in the last year or any evidence of functional impairment due to and persisting after head trauma
- Motor movement disorder which may cause sudden excessive movement, such as Tourette's disorder
- Birth before 32 weeks of gestation. Premature birth can have a profound effect on brain function and structure
- A known neurological or neurogenetic condition affecting the central nervous system, such as epilepsy, cerebral palsy, neurofibromatosis, velo-cardiofacial syndrome.
- Color blindness
Typically Developing Group:
- Cognitive impairment, defined as Nonverbal IQ below 80, or signs of ASD or ADHD
- Confirmed diagnosis of any DSM-IV-TR Axis I disorder
- Taking medications for neuropsychiatric disorders such as antidepressants, antipsychotics, mood stabilizers, anxiolytics or any medication used to treat ADHD (psychostimulants, atomoxetine (Strattera(Registered Trademark)), bupropion (Wellbutrin(Registered Trademark)), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil(Registered Trademark)).
ASD Group:
- Taking medications for neuropsychiatric disorders: such as antidepressants, antipsychotics, mood stabilizers, or anxiolytics. Some medications used to treatment for ADHD are also exclusionary for all children - including atomoxetine (Strattera(Registered Trademark)), bupropion (Wellbutrin(Registered Trademark)), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil(Registered Trademark)). Children with ASD who take stimulants (like Ritalin, adderall, concerta and vyvanse) may be able to participate if they are willing and able to stop stimulant medications for 2 days on 1 occasion for the study
- A known neurological or neurogenetic condition affecting the central nervous system, such as epilepsy, cerebral palsy, neurofibromatosis, velo-cardiofacial syndrome.
- Presence of symptoms of ADHD in the clinical range, based on diagnostic evaluation conducted through a separate screening protocol
ADHD Group:
- Taking medications for neuropsychiatric disorders: such as antidepressants, antipsychotics, mood stabilizers, or anxiolytics. Some medications used to treatment for ADHD are also exclusionary for all children - including atomoxetine (Strattera(Registered Trademark)), bupropion (Wellbutrin(Registered Trademark)), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil(Registered Trademark)). Children with ASD who take stimulants (like Ritalin, adderall, concerta and vyvanse) may be able to participate if they are willing and able to stop stimulant medications for 2 days on 1 occasion for the study
- Other psychiatric diagnoses (including ASD, anxiety and depression), except for comorbid oppostional defiant disorder
Contacts and Locations| Contact: Margaret J Pekar | (301) 402-1084 | pekarm@mail.nih.gov |
| Contact: Audrey E Thurm, Ph.D. | (301) 496-5323 | at191u@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Audrey E Thurm, Ph.D. | National Institute of Mental Health (NIMH) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) |
| ClinicalTrials.gov Identifier: | NCT01730079 History of Changes |
| Other Study ID Numbers: | 130007, 13-M-0007 |
| Study First Received: | November 17, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Attention Deficit Hyperactivity Disorder Autism Near Infrared Spectroscopy Brain Activity |
Additional relevant MeSH terms:
|
Autistic Disorder Attention Deficit Disorder with Hyperactivity Hyperkinesis Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
Attention Deficit and Disruptive Behavior Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013