- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00956579
Sensory and Connectivity Abnormalities in Autism Spectrum Disorders
MEG/EEG/MRI and Psychophysics Study of Developmental Disorders
Descripción general del estudio
Estado
Condiciones
Descripción detallada
(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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicole McGuiggan, Rsch Coord
- Número de teléfono: 617-966-9766
- Correo electrónico: TRANSCEND@partners.org
Ubicaciones de estudio
-
-
Massachusetts
-
Charlestown, Massachusetts, Estados Unidos, 02129
- Reclutamiento
- Martinos Center or Biomedical Imaging
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Otro
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Healthy individuals
No intervention Healthy participants ages 14-32 for a neuroimaging study |
Individuos con Trastorno del Espectro Autista
Sin intervención Participantes con TEA de 14 a 32 años para un estudio de neuroimagen. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Saliency of Sensory Stimuli in Developmental Disorders
Periodo de tiempo: up to 2 years
|
up to 2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tal Kenet, Ph.D, Massachusetts General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2005P001768
- 5R01MH117998 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .