We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensory and Connectivity Abnormalities in Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00956579
Recruitment Status : Recruiting
First Posted : August 11, 2009
Last Update Posted : September 18, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tal Kenet, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI.

Condition or disease
Autism Spectrum Disorder

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Other
Official Title: MEG/EEG/MRI and Psychophysics Study of Developmental Disorders
Actual Study Start Date : June 2013
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Saliency of Sensory Stimuli in Developmental Disorders [ Time Frame: up to 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 32 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult/Pediatric
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956579


Contacts
Layout table for location contacts
Contact: Nicole McGuiggan, Rsch Coord 617-966-9766 TRANSCEND@partners.org

Locations
Layout table for location information
United States, Massachusetts
Martinos Center or Biomedical Imaging Recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Tal Kenet, Ph.D Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tal Kenet, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00956579    
Other Study ID Numbers: 2005P001768
5R01MH117998 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Keywords provided by Tal Kenet, Massachusetts General Hospital:
autism
autistic
sensory
MEG
connectivity
brain
MRI
 language
developmental
neurodevelopmental
aspergers
asperger's
coherence
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders