Autism Spectrum DisorderNCT00956579
Sensory and Connectivity Abnormalities in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI. Read more about this study
- Who is it for?
- Ages 14 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2025
- 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 14 to 32 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adult/Pediatric
Who may be able to join
- All of the following criteria must be met by all participants:
- The participant or the participant's legal guardian is able to understand and is willing to comply with the requirements of the study
- The participant meets the age requirements (14-32 years old)
- The participant or legal guardian has signed an Informed Consent Form specific to this study, and is able to understand the consent form.
- The participant must have English as their first language.
- The participant must have a non-verbal IQ > 70
- For the ASD/language disorder group only:
- Autism Spectrum Disorder: Participants must meet criteria for Autism Spectrum Disorder on the ADOS.
Who cannot join
- The following exclusion criteria apply to both control and autism groups:
- Any volunteer for whom informed consent cannot be obtained
- Volunteers with metal braces, extensive dental work involving metals, implanted electromagnetically activated medical equipment (cardiac pacemakers, neurostimulators, functioning infusion pumps), all of which would interfere with the MEG signal, will be excluded from the MEG portion of the study
- Volunteers with any medically diagnosed sensory loss
- Volunteers with a known genetic disorder (e.g. Tourette's syndrome, etc), or other medical condition affecting the brain, such as progressive encephalopathy as well as those who are on high doses of multiple anti-seizure medications and have frequent, uncontrolled seizures
- Asphyxia at birth or any other time, premature birth (Fewer than 34 weeks gestation)
Show all 13Show fewer
- For the control group only:
- Volunteers diagnosed with a mental condition such as depression, anxiety, aggression, hyperactivity, attention deficit disorder (with or without hyperactivity).
- Volunteers who score below the autism spectrum cut-off (in the normal range) on the ADOS and SCQ
- Volunteers on any sort of neuro-psychopharmacological treatment (including antidepressants, stimulants, antipsychotics, anticonvulsants, benzodiazepines).
- For the autism group only:
- Children or adults not meeting criteria for autism spectrum disorder
- Volunteers with co-morbid disorders such as tuberous sclerosis or fragile X.
Trial locations and contacts
1 site in 1 country.
United States1 site
Martinos Center or Biomedical Imaging
Charlestown, Massachusetts, 02129
About this study
Official title: MEG/EEG/MRI and Psychophysics Study of Developmental Disorders
Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI.
Read the detailed description
(NOTE: we are currently recruiting individuals between the ages of 14 and 32, either typically developing or with an autism spectrum disorder.)
To study how sensory information is processed by the brain, we primarily use an instrument called MEG (MagnetoEncephaloGraphy), which measures the magnetic brainwaves emitted by our brains. The device does not have any output (i.e., there is no magnetic field); it only measures the waves produced in the brain.
We measure those waves as the participants in the study listen to, view, or otherwise experience simple, non painful, stimuli. For instance, participants may listen to words while sitting in the MEG room, and watching a movie with the sound turned off.
We then combine this information with pictures of the brain from MRI (Magnetic Resonance Imaging - when available), to get an idea about both the anatomy and the function of the brain, so that we can study how the brains of populations with autism spectrum disorders or language disorders may be different from those of typically developing populations.
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, autistic, sensory, MEG, connectivity, brain, MRI, language, developmental, neurodevelopmental, aspergers, asperger's, coherence
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Language
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 |
|---|---|---|
| Healthy individuals | No intervention Healthy participants ages 14-32 for a neuroimaging study | |
| Individuals with Autism Spectrum Disorder | No intervention ASD participants ages 14-32 for a neuroimaging study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliency of Sensory Stimuli in Developmental Disorders
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startJun 2013
- Primary completionJun 2025
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tal Kenet, Massachusetts General Hospital
- Investigators
- Tal Kenet, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956579
- Sponsor's protocol ID
- 2005P001768
- Other IDs
- 5R01MH117998
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2007
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEG/EEG/MRI and Psychophysics Study of Developmental Disorders
- ClinicalTrials.gov ID
- NCT00956579
- Acronym / sponsor ID
- 2005P001768
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, autistic, sensory, MEG, connectivity, brain, MRI, language
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2025 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 11 Aug 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.
Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI.
Detailed description
(NOTE: we are currently recruiting individuals between the ages of 14 and 32, either typically developing or with an autism spectrum disorder.)
To study how sensory information is processed by the brain, we primarily use an instrument called MEG (MagnetoEncephaloGraphy), which measures the magnetic brainwaves emitted by our brains. The device does not have any output (i.e., there is no magnetic field); it only measures the waves produced in the brain.
We measure those waves as the participants in the study listen to, view, or otherwise experience simple, non painful, stimuli. For instance, participants may listen to words while sitting in the MEG room, and watching a movie with the sound turned off.
We then combine this information with pictures of the brain from MRI (Magnetic Resonance Imaging - when available), to get an idea about both the anatomy and the function of the brain, so that we can study how the brains of populations with autism spectrum disorders or language disorders may be different from those of typically developing populations.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –No intervention Healthy participants ages 14-32 for a neuroimaging study |
| Individuals with Autism Spectrum Disorder | – | –No intervention ASD participants ages 14-32 for a neuroimaging study. |
Who may qualify
- Ages
- 14 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adult/Pediatric
Key inclusion criteria (8 listed)
- All of the following criteria must be met by all participants:
- For the ASD/language disorder group only:
Key exclusion criteria (13 listed)
- The following exclusion criteria apply to both control and autism groups:
- For the control group only:
- For the autism group only:
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
Saliency of Sensory Stimuli in Developmental Disorders
Time frame: up to 2 years
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 24 Apr 2026.
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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.
Tal Kenet, Ph.D principal investigator
Massachusetts General Hospital
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 Autism Spectrum Disorder, run by Massachusetts General Hospital 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 8 inclusion and 13 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 24 Apr 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?
Saliency of Sensory Stimuli in Developmental Disorders (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.