- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00956579
Sensory and Connectivity Abnormalities in Autism Spectrum Disorders
MEG/EEG/MRI and Psychophysics Study of Developmental Disorders
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Nicole McGuiggan, Rsch Coord
- Telefonnummer: 617-966-9766
- E-post: TRANSCEND@partners.org
Studiesteder
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Massachusetts
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Charlestown, Massachusetts, Forente stater, 02129
- Rekruttering
- Martinos Center or Biomedical Imaging
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Annen
Kohorter og intervensjoner
Gruppe / Kohort |
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Healthy individuals
No intervention Healthy participants ages 14-32 for a neuroimaging study |
Personer med autismespekterforstyrrelse
Ingen inngrep ASD-deltakere i alderen 14-32 år for en nevroavbildningsstudie. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Saliency of Sensory Stimuli in Developmental Disorders
Tidsramme: up to 2 years
|
up to 2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tal Kenet, Ph.D, Massachusetts General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2005P001768
- 5R01MH117998 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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