Asperger's DisorderNCT01031407
Cognitive Neuroscience of Autism Spectrum Disorders
An observational study of Asperger's Disorder and Mental Retardation, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Read more about this study
- Who is it for?
- Ages 5 to 89 years
- Conditions the study is for
- Asperger's Disorder, Mental Retardation, Children
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2010to not given
- 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 5 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children, adolescents, and adults with autism spectrum disorders (ASDs), controls (i.e., typically developing children, adolescents, and adults and children with mild to moderate intellectual disability), as well as caregivers/legal guardians/parents of these individuals.
Who may be able to join
- Subjects will include:
- males and females.
- 5-89 years of age.
- A minimum IQ of 70
- Subjects in the ASD group will:
- meet DSM-IV criteria for one of the pervasive developmental disorders (i.e., autistic disorder, Asperger disorder, or pervasive developmental disorder-not otherwise specified).
Show all 12Show fewer
- meet or pass the autism cut-off score for social symptoms on the ADI and/or the ASD cut-off score from social+communication symptoms on the ADOS.
- be able to provide their own consent (for adults).
- For inclusion in the facial recognition substudy, subjects must be:
- ages 18 to 35
- in good health
- with bad memory of faces
Who cannot join
- All subjects, except for savants, also will be excluded if they have:
- a history of neurological insult/injury.
- substantial prenatal drug exposure known to affect later brain and behavior (e.g., cocaine, alcohol).
- severely premature birth or birth trauma.
- severe medical disorder (e.g., neurofibromatosis, hydrocephalus, cerebral palsy, uncontrollable seizure disorder).
- a known genetic disorder (e.g., Fragile X or Down syndrome) that would be expected to significantly impact findings from cognitive testing and/or neuroimaging.
Show all 11Show fewer
- Furthermore, subjects will be excluded from MRI/MEG studies, if they have:
- any exclusion from MRI scanning including: the presence of metal in their body, having a pacemaker, and/or females who are pregnant.
- Healthy volunteers, except for parents of individuals with autism spectrum disorders and parents of healthy volunteers, will also be excluded if they have:
- 1. a current or past history of axis I psychiatric conditions or any current usage of psychiatric medication.
- Savants have less restrictive exclusionary criteria because: 1) they are a very rare group, thus we don t want to limit recruitment further and 2) we can examine common and unique cognitive mechanisms across savants, a question of keen interest, regardless of co-morbidities. Those with tumors or other neuroimaging-relevant contraindications will be excluded from fMRI/MEG procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison.
- By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD.
Read more
Objectives:
- To learn more about the brain in healthy people and in people with autism spectrum disorders.
- To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants.
Eligibility:
The following groups of participants will be eligible for the study:
- Individuals between 5 and 89 years of age who have autism spectrum disorders.
- Healthy volunteers between 5 and 89 years of age.
- Cognitively impaired children between 5 and 17 years of age.
- Parents/caregivers/legal guardians of individuals in the above three groups.
Design:
- Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant.
- Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG).
- The study will also collect blood or saliva to obtain a DNA sample.
Read the detailed description
Objective: The primary objective of the proposed studies is to utilize neuroimaging (functional Magnetic Resonance Imaging [fMRI], structural MRI [sMRI], Magnetoencephalography [MEG]) and neuropsychological tools (eye-tracking, cognitive experiments, clinical neuropsychological measures, questionnaires, etc.) to identify cognitive idiosyncrasies (e.g., social-cognitive deficits, visual perceptual assets, and savant skills) characteristic of individuals on the autism spectrum and their neural underpinnings across childhood and adulthood.
Study Population: Children, adolescents, and adults with autism spectrum disorders (ASDs), controls (i.e., typically developing children, adolescents, and adults and those with mild to moderate mental retardation), as well as caregivers/legal guardians/parents of these individuals.
Design: Descriptive/Characterization/Observational studies using primarily neuropsychological and neuroimaging methodologies.
Outcome Measures: Behavioral (reaction time, accuracy, eye movements, etc.) and neuroimaging (brain morphometry, BOLD, electrophysiology, etc.).
- Keywords
- Social Cognition, Autism, Functional Magnetic Resonance Imaging (fMRI), MEG, Structural MRI, Natural History
- Medical subject headings
- Asperger Syndrome, Intellectual Disability, Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy Volunteers | |
| Group 2 | Individuals with Autism Spectrum Disorders | |
| Group 3 | Parents of Healthy Volunteers, or Individuals with Autism Spectrum Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive and neurological phenotypes in ASD and control participants
Cognitive tasks and neuroimaging
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start21 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Asperger's DisorderStudies 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
- Cross-sectional
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christopher I Baker, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031407
- Sponsor's protocol ID
- 100027
- Other IDs
- 10-M-0027
- Status last verified
- 27 May 2026
- First submitted
- 11 Dec 2009
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Persichetti AS, Shao J, Gotts SJ, Martin A. A functional parcellation of the whole brain in high-functioning individuals with autism spectrum disorder reveals atypical patterns of network organization. Mol Psychiatry. 2025 Apr;30(4):1518-1528. doi: 10.1038/s41380-024-02764-6. Epub 2024 Sep 30.
PubMed 39349967Lynch CJ, Silver BM, Dubin MJ, Martin A, Voss HU, Jones RM, Power JD. Prevalent and sex-biased breathing patterns modify functional connectivity MRI in young adults. Nat Commun. 2020 Oct 20;11(1):5290. doi: 10.1038/s41467-020-18974-9.
PubMed 33082311Avery JA, Liu AG, Ingeholm JE, Riddell CD, Gotts SJ, Martin A. Taste Quality Representation in the Human Brain. J Neurosci. 2020 Jan 29;40(5):1042-1052. doi: 10.1523/JNEUROSCI.1751-19.2019. Epub 2019 Dec 13.
PubMed 31836661Power JD, Lynch CJ, Gilmore AW, Gotts SJ, Martin A. Reply to Spreng et al.: Multiecho fMRI denoising does not remove global motion-associated respiratory signals. Proc Natl Acad Sci U S A. 2019 Sep 24;116(39):19243-19244. doi: 10.1073/pnas.1909852116. Epub 2019 Aug 27. No abstract available.
PubMed 31455743Ramot M, Walsh C, Martin A. Multifaceted Integration: Memory for Faces Is Subserved by Widespread Connections between Visual, Memory, Auditory, and Social Networks. J Neurosci. 2019 Jun 19;39(25):4976-4985. doi: 10.1523/JNEUROSCI.0217-19.2019. Epub 2019 Apr 29.
PubMed 31036762Smith REW, Avery JA, Wallace GL, Kenworthy L, Gotts SJ, Martin A. Sex Differences in Resting-State Functional Connectivity of the Cerebellum in Autism Spectrum Disorder. Front Hum Neurosci. 2019 Apr 5;13:104. doi: 10.3389/fnhum.2019.00104. eCollection 2019.
PubMed 31024276Jasmin K, Gotts SJ, Xu Y, Liu S, Riddell CD, Ingeholm JE, Kenworthy L, Wallace GL, Braun AR, Martin A. Overt social interaction and resting state in young adult males with autism: core and contextual neural features. Brain. 2019 Mar 1;142(3):808-822. doi: 10.1093/brain/awz003.
PubMed 30698656Crutcher J, Martin A, Wallace GL. Dissociations in the neural substrates of language and social functioning in autism spectrum disorder. Autism Res. 2018 Aug;11(8):1175-1186. doi: 10.1002/aur.1969.
PubMed 30365251Avery JA, Ingeholm JE, Wohltjen S, Collins M, Riddell CD, Gotts SJ, Kenworthy L, Wallace GL, Simmons WK, Martin A. Neural correlates of taste reactivity in autism spectrum disorder. Neuroimage Clin. 2018 Apr 4;19:38-46. doi: 10.1016/j.nicl.2018.04.008. eCollection 2018.
PubMed 30035000Power JD, Plitt M, Gotts SJ, Kundu P, Voon V, Bandettini PA, Martin A. Ridding fMRI data of motion-related influences: Removal of signals with distinct spatial and physical bases in multiecho data. Proc Natl Acad Sci U S A. 2018 Feb 27;115(9):E2105-E2114. doi: 10.1073/pnas.1720985115. Epub 2018 Feb 12.
PubMed 29440410Power JD, Plitt M, Laumann TO, Martin A. Sources and implications of whole-brain fMRI signals in humans. Neuroimage. 2017 Feb 1;146:609-625. doi: 10.1016/j.neuroimage.2016.09.038. Epub 2016 Oct 15.
PubMed 27751941Power JD. A simple but useful way to assess fMRI scan qualities. Neuroimage. 2017 Jul 1;154:150-158. doi: 10.1016/j.neuroimage.2016.08.009. Epub 2016 Aug 7.
PubMed 27510328Eisenberg IW, Wallace GL, Kenworthy L, Gotts SJ, Martin A. Insistence on sameness relates to increased covariance of gray matter structure in autism spectrum disorder. Mol Autism. 2015 Oct 1;6:54. doi: 10.1186/s13229-015-0047-7. eCollection 2015.
PubMed 26435832Martin A. GRAPES-Grounding representations in action, perception, and emotion systems: How object properties and categories are represented in the human brain. Psychon Bull Rev. 2016 Aug;23(4):979-90. doi: 10.3758/s13423-015-0842-3.
PubMed 25968087Plitt M, Barnes KA, Martin A. Functional connectivity classification of autism identifies highly predictive brain features but falls short of biomarker standards. Neuroimage Clin. 2014 Dec 24;7:359-66. doi: 10.1016/j.nicl.2014.12.013. eCollection 2015.
PubMed 25685703
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Neuroscience of Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01031407
- Acronym / sponsor ID
- 100027
- Keywords
- Social Cognition, Autism, Functional Magnetic Resonance Imaging (fMRI), MEG, Structural MRI, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 21 Feb 2010 (actual)
- First posted
- 14 Dec 2009 (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:
- Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison.
- By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD.
Objectives:
- To learn more about the brain in healthy people and in people with autism spectrum disorders.
- To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants.
Eligibility:
The following groups of participants will be eligible for the study:
- Individuals between 5 and 89 years of age who have autism spectrum disorders.
- Healthy volunteers between 5 and 89 years of age.
- Cognitively impaired children between 5 and 17 years of age.
- Parents/caregivers/legal guardians of individuals in the above three groups.
Design:
- Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant.
- Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG).
- The study will also collect blood or saliva to obtain a DNA sample.
Detailed description
Objective: The primary objective of the proposed studies is to utilize neuroimaging (functional Magnetic Resonance Imaging [fMRI], structural MRI [sMRI], Magnetoencephalography [MEG]) and neuropsychological tools (eye-tracking, cognitive experiments, clinical neuropsychological measures, questionnaires, etc.) to identify cognitive idiosyncrasies (e.g., social-cognitive deficits, visual perceptual assets, and savant skills) characteristic of individuals on the autism spectrum and their neural underpinnings across childhood and adulthood.
Study Population: Children, adolescents, and adults with autism spectrum disorders (ASDs), controls (i.e., typically developing children, adolescents, and adults and those with mild to moderate mental retardation), as well as caregivers/legal guardians/parents of these individuals.
Design: Descriptive/Characterization/Observational studies using primarily neuropsychological and neuroimaging methodologies.
Outcome Measures: Behavioral (reaction time, accuracy, eye movements, etc.) and neuroimaging (brain morphometry, BOLD, electrophysiology, etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Healthy Volunteers |
| Group 2 | – | –Individuals with Autism Spectrum Disorders |
| Group 3 | – | –Parents of Healthy Volunteers, or Individuals with Autism Spectrum Disorders |
Who may qualify
- Ages
- 5 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, adolescents, and adults with autism spectrum disorders (ASDs), controls (i.e., typically developing children, adolescents, and adults and children with mild to moderate intellectual disability), as well as caregivers/legal guardians/parents of these individuals.
Key inclusion criteria (12 listed)
- males and females.
- 5-89 years of age.
- A minimum IQ of 70
- meet DSM-IV criteria for one of the pervasive developmental disorders (i.e., autistic disorder, Asperger disorder, or pervasive developmental disorder-not otherwise specified).
- meet or pass the autism cut-off score for social symptoms on the ADI and/or the ASD cut-off score from social+communication symptoms on the ADOS.
Key exclusion criteria (11 listed)
- a history of neurological insult/injury.
- substantial prenatal drug exposure known to affect later brain and behavior (e.g., cocaine, alcohol).
- severely premature birth or birth trauma.
- severe medical disorder (e.g., neurofibromatosis, hydrocephalus, cerebral palsy, uncontrollable seizure disorder).
- a known genetic disorder (e.g., Fragile X or Down syndrome) that would be expected to significantly impact findings from cognitive testing and/or neuroimaging.
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
Cognitive and neurological phenotypes in ASD and control participants
Time frame: Ongoing
Cognitive tasks and neuroimaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 39349967Persichetti AS, Shao J, Gotts SJ, Martin A. A functional parcellation of the whole brain in high-functioning individuals with autism spectrum disorder reveals atypical patterns of network organization. Mol Psychiatry. 2025 Apr;30(4):1518-1528. doi: 10.1038/s41380-024-02764-6. Epub 2024 Sep 30.
- Derived from this study: PubMed 33082311Lynch CJ, Silver BM, Dubin MJ, Martin A, Voss HU, Jones RM, Power JD. Prevalent and sex-biased breathing patterns modify functional connectivity MRI in young adults. Nat Commun. 2020 Oct 20;11(1):5290. doi: 10.1038/s41467-020-18974-9.
- Derived from this study: PubMed 31836661Avery JA, Liu AG, Ingeholm JE, Riddell CD, Gotts SJ, Martin A. Taste Quality Representation in the Human Brain. J Neurosci. 2020 Jan 29;40(5):1042-1052. doi: 10.1523/JNEUROSCI.1751-19.2019. Epub 2019 Dec 13.
- Derived from this study: PubMed 31455743Power JD, Lynch CJ, Gilmore AW, Gotts SJ, Martin A. Reply to Spreng et al.: Multiecho fMRI denoising does not remove global motion-associated respiratory signals. Proc Natl Acad Sci U S A. 2019 Sep 24;116(39):19243-19244. doi: 10.1073/pnas.1909852116. Epub 2019 Aug 27. No abstract available.
- Derived from this study: PubMed 31036762Ramot M, Walsh C, Martin A. Multifaceted Integration: Memory for Faces Is Subserved by Widespread Connections between Visual, Memory, Auditory, and Social Networks. J Neurosci. 2019 Jun 19;39(25):4976-4985. doi: 10.1523/JNEUROSCI.0217-19.2019. Epub 2019 Apr 29.
- Derived from this study: PubMed 31024276Smith REW, Avery JA, Wallace GL, Kenworthy L, Gotts SJ, Martin A. Sex Differences in Resting-State Functional Connectivity of the Cerebellum in Autism Spectrum Disorder. Front Hum Neurosci. 2019 Apr 5;13:104. doi: 10.3389/fnhum.2019.00104. eCollection 2019.
- Derived from this study: PubMed 30698656Jasmin K, Gotts SJ, Xu Y, Liu S, Riddell CD, Ingeholm JE, Kenworthy L, Wallace GL, Braun AR, Martin A. Overt social interaction and resting state in young adult males with autism: core and contextual neural features. Brain. 2019 Mar 1;142(3):808-822. doi: 10.1093/brain/awz003.
- Derived from this study: PubMed 30365251Crutcher J, Martin A, Wallace GL. Dissociations in the neural substrates of language and social functioning in autism spectrum disorder. Autism Res. 2018 Aug;11(8):1175-1186. doi: 10.1002/aur.1969.
- Derived from this study: PubMed 30035000Avery JA, Ingeholm JE, Wohltjen S, Collins M, Riddell CD, Gotts SJ, Kenworthy L, Wallace GL, Simmons WK, Martin A. Neural correlates of taste reactivity in autism spectrum disorder. Neuroimage Clin. 2018 Apr 4;19:38-46. doi: 10.1016/j.nicl.2018.04.008. eCollection 2018.
- Derived from this study: PubMed 29440410Power JD, Plitt M, Gotts SJ, Kundu P, Voon V, Bandettini PA, Martin A. Ridding fMRI data of motion-related influences: Removal of signals with distinct spatial and physical bases in multiecho data. Proc Natl Acad Sci U S A. 2018 Feb 27;115(9):E2105-E2114. doi: 10.1073/pnas.1720985115. Epub 2018 Feb 12.
- Derived from this study: PubMed 27751941Power JD, Plitt M, Laumann TO, Martin A. Sources and implications of whole-brain fMRI signals in humans. Neuroimage. 2017 Feb 1;146:609-625. doi: 10.1016/j.neuroimage.2016.09.038. Epub 2016 Oct 15.
- Derived from this study: PubMed 27510328Power JD. A simple but useful way to assess fMRI scan qualities. Neuroimage. 2017 Jul 1;154:150-158. doi: 10.1016/j.neuroimage.2016.08.009. Epub 2016 Aug 7.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Christopher I Baker, 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 Asperger's Disorder and Mental Retardation, 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 8 Oct 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive and neurological phenotypes in ASD and control participants (time frame: Ongoing). 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 NCT01031407, which also lists 17 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 8 Oct 2026.