Attention Deficit Disorder With HyperactivityNCT01730079
Near Infrared Spectroscopy in Children With Autism and ADHD
An observational study of Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2012to 11 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 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
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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 ), bupropion (Wellbutrin ), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil ).
- 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 ), bupropion (Wellbutrin ), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil ). 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.
- 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 ), bupropion (Wellbutrin ), tricyclic antidepressants (like impramine), clonidine, guanfacine, or modafinil (Provigil ). 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Near Infra-Red Spectroscopy (NIRS) in Neurodevelopmental Disorders and Typically Developing Children
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.
Read more
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.
Read the 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.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, Autism, Autism Spectrum Disorders
- Keywords
- Attention Deficit Hyperactivity Disorder, Autism, Near Infrared Spectroscopy, Brain Activity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.
Secondary outcomes (1)
Differential activity according to region of the frontal cortext and task elements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start23 Oct 2012
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Audrey E Thurm, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730079
- Sponsor's protocol ID
- 130007
- Other IDs
- 13-M-0007
- Status last verified
- 11 Apr 2017
- First submitted
- 17 Nov 2012
- Last updated
- 18 Oct 2019
- Results posted
- No
Publications
Boas DA, Dale AM, Franceschini MA. Diffuse optical imaging of brain activation: approaches to optimizing image sensitivity, resolution, and accuracy. Neuroimage. 2004;23 Suppl 1:S275-88. doi: 10.1016/j.neuroimage.2004.07.011.
PubMed 15501097Carlsson J, Lagercrantz H, Olson L, Printz G, Bartocci M. Activation of the right fronto-temporal cortex during maternal facial recognition in young infants. Acta Paediatr. 2008 Sep;97(9):1221-5. doi: 10.1111/j.1651-2227.2008.00886.x.
PubMed 18627358Elwell CE, Henty JR, Leung TS, Austin T, Meek JH, Delpy DT, Wyatt JS. Measurement of CMRO2 in neonates undergoing intensive care using near infrared spectroscopy. Adv Exp Med Biol. 2005;566:263-8. doi: 10.1007/0-387-26206-7_35.
PubMed 16594161
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infra-Red Spectroscopy (NIRS) in Neurodevelopmental Disorders and Typically Developing Children
- ClinicalTrials.gov ID
- NCT01730079
- Acronym / sponsor ID
- 130007
- Conditions
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, Autism, Autism Spectrum Disorders
- Keywords
- Attention Deficit Hyperactivity Disorder, Autism, Near Infrared Spectroscopy, Brain Activity
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 23 Oct 2012
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- -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 Fourth Edition , no more than 1.5 standard deviation below the mean)
- -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
- -Diagnosis of ADHD based on diagnostic evaluation conducted through a separate screening protocol Minimum Nonverbal IQ of 80; Minimum Verbal IQ score of 60
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.
1 secondary outcome
Differential activity according to region of the frontal cortext and task elements.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Background: PubMed 15501097Boas DA, Dale AM, Franceschini MA. Diffuse optical imaging of brain activation: approaches to optimizing image sensitivity, resolution, and accuracy. Neuroimage. 2004;23 Suppl 1:S275-88. doi: 10.1016/j.neuroimage.2004.07.011.
- Background: PubMed 18627358Carlsson J, Lagercrantz H, Olson L, Printz G, Bartocci M. Activation of the right fronto-temporal cortex during maternal facial recognition in young infants. Acta Paediatr. 2008 Sep;97(9):1221-5. doi: 10.1111/j.1651-2227.2008.00886.x.
- Background: PubMed 16594161Elwell CE, Henty JR, Leung TS, Austin T, Meek JH, Delpy DT, Wyatt JS. Measurement of CMRO2 in neonates undergoing intensive care using near infrared spectroscopy. Adv Exp Med Biol. 2005;566:263-8. doi: 10.1007/0-387-26206-7_35.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey E Thurm, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.