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Sensory and Connectivity Abnormalities in Autism and Language Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Autism Speaks
Nancy Lurie Marks Family Foundation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00956579
First received: October 23, 2007
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

Among the most commonly reported symptoms of autism is heightened sensitivity to sensory stimuli. Children and adults with autism spectrum disorders often react with aversion to various sounds (e.g., by covering their ears and screaming) especially at an early age. The investigators believe that this is because autism spectrum disorders affect how sensory input is experienced. Therefore, the purpose of this study is to investigate sensory processing abnormalities in autism spectrum disorders, or, in other words, to evaluate how and why children and adults with autism spectrum disorders experience external sensory information (vision, audition, touch) differently than healthy children and adults.

Because some of the same abnormalities are also reported in children and adults with developmental language disorders such as language delay or dyslexia, the investigators are also interested in how that population experiences external sensory information.


Condition
Autism Spectrum Disorder
Developmental Language Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Psychophysics and Neurodynamic MEG/EEG Imaging of Sensory and Connectivity Abnormalities in Neurodevelopmental Disorders.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 260
Study Start Date: September 2005
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Participants with a neurodevelopmental disorder.
2
Participants WITHOUT a neurodevelopmental disorder.

Detailed Description:

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 healthy populations.

  Eligibility

Ages Eligible for Study:   6 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Massachusetts General Hospital other institution: Cambridge Hospital Child Development Center

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 (6-45 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 > 80
  • For the ASD/language disorder group only:

    • Autism Spectrum Disorder: Participants must meet criteria for Autism Spectrum Disorder on BOTH the ADI-R and the ADOS.
    • Language Disorder: Participants will evidence expressive and receptive language disorders as indicated by a combination of standard scores 1.3 Standard Deviations below the mean for their age on at least 3 of the 4 Core Subtests of the CELF-IV, and on at least one of the following: Test for the Reception of Grammar, Expressive Vocabulary Test, or the Peabody Preschool Vocabulary Test will be included.

Exclusion Criteria:

  • The following exclusion criteria apply to both control and autism groups:

    • Any volunteer for whom informed consent cannot be obtained
    • Volunteers diagnosed with a mental condition such as depression, anxiety, aggression, hyperactivity, attention deficit disorder (with or without hyperactivity).
    • 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 (Greater than 37 weeks gestation)
  • For the control group only

    • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956579

Contacts
Contact: Alyssa Orinstein, Rsch Coord 617-966-9766 TRANSCEND@partners.org

Locations
United States, Massachusetts
Martinos Center or Biomedical Imaging Recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Autism Speaks
Nancy Lurie Marks Family Foundation
Investigators
Principal Investigator: Tal Kenet, Ph.D Massachusetts General Hospital
Principal Investigator: Martha Herbert, MD, Ph.D Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Tal Kenet, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00956579     History of Changes
Other Study ID Numbers: 2005P001768
Study First Received: October 23, 2007
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
autism
autistic
sensory
MEG
connectivity
brain
MRI
language
developmental
neurodevelopmental
aspergers
asperger's
dyslexia
coherence

Additional relevant MeSH terms:
Language Disorders
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Language Development Disorders
Communication Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014