Sensory and Connectivity Abnormalities in Autism Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT00956579|
Recruitment Status : Recruiting
First Posted : August 11, 2009
Last Update Posted : September 18, 2020
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|Condition or disease|
|Autism Spectrum Disorder|
(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 Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
Healthy participants ages 14-32 for a neuroimaging study
Individuals with Autism Spectrum Disorder
ASD participants ages 14-32 for a neuroimaging study.
- Saliency of Sensory Stimuli in Developmental Disorders [ Time Frame: up to 2 years ]
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|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|
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.
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.
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
|Contact: Nicole McGuiggan, Rsch Coord||617-966-9766||TRANSCEND@partners.org|
|United States, Massachusetts|
|Martinos Center or Biomedical Imaging||Recruiting|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Tal Kenet, Ph.D||Massachusetts General Hospital|
|Responsible Party:||Tal Kenet, Associate Professor, Massachusetts General Hospital|
|Other Study ID Numbers:||
5R01MH117998 ( U.S. NIH Grant/Contract )
|First Posted:||August 11, 2009 Key Record Dates|
|Last Update Posted:||September 18, 2020|
|Last Verified:||September 2020|
Autism Spectrum Disorder
Child Development Disorders, Pervasive