- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00956579
Sensory and Connectivity Abnormalities in Autism Spectrum Disorders
MEG/EEG/MRI and Psychophysics Study of Developmental Disorders
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
(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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Nicole McGuiggan, Rsch Coord
- Telefonnummer: 617-966-9766
- E-mail: TRANSCEND@partners.org
Studiesteder
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-
Massachusetts
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Charlestown, Massachusetts, Forenede Stater, 02129
- Rekruttering
- Martinos Center or Biomedical Imaging
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Andet
Kohorter og interventioner
Gruppe / kohorte |
---|
Healthy individuals
No intervention Healthy participants ages 14-32 for a neuroimaging study |
Personer med autismespektrumforstyrrelse
Ingen indgriben ASD-deltagere i alderen 14-32 til en neuroimaging undersøgelse. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Saliency of Sensory Stimuli in Developmental Disorders
Tidsramme: up to 2 years
|
up to 2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tal Kenet, Ph.D, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2005P001768
- 5R01MH117998 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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