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Clinical Trials/NCT00319722
NCT00319722UnknownNot Applicable

Electrophysiologic Indicators of Gating and Timing Abnormalities in Autism

Massachusetts General Hospital1 site in 1 country130 target enrollmentStarted: February 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
130
Locations
1
Primary Endpoint
EEG and ERP abnormalities

Study Overview

Brief Summary

This study uses EEG to study brain waves at rest and in response to specific auditory and visual sensory stimuli in autistic children. We hypothesize that, compared to same age peers, autistics will show abnormalities in their electrophysiologic processing of sounds (tones and phonemes)and visual stimuli (flashes of light)and that these abnormalities will be able to separate autistics not only from typical children but also into clinical subgroups with specific biological/electrophysiological characteristics. We hope to find biological measures which will prove diagnostic of autism in very young children and which can be used in the measurement of treatment outcome in future intervention trials.

Detailed Description

Specific Aims:

Aim 1: To recruit 75 children with autism and 75 age- and sex-matched controls ages 6 to 8 years old for an electrophysiological study and to characterize the subjects using appropriate instruments for autism diagnosis, language functioning and behavior/sensory profile, and to measure head circumferences Aim 2: To acquire and analyze event-related potential (ERP) data in the auditory and visual modality.

ERP Hypothesis: Increased amplitude, altered morphology, impaired temporal discrimination and delayed responsiveness will be found early in the processing hierarchy, and the severity of these abnormalities will be associated with the severity of dysfunction at higher levels of cortical processing.

Aim 3: To acquire EEG data and to analyze it quantitatively. Quantitative EEG Hypothesis: Both interhemispheric and intrahemispheric coherence measures of the EEG will be significantly deviant from those in the normal sample and predicted by abnormalities of ERPs. In addition, EEG background alpha activity will show post mature (i.e. higher) frequencies (Hz) than would be expected for age and focal epileptiform activity and slowing (i.e. paroxysmal theta) will predict dysfunction on the ERPs.

Rationale:

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
3 Months to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • autistic children or their younger siblings between the ages of 3 months to 8 year
  • Controls: typically developing children 3mo to 8 years without known language or social disorder and not related to child with autism

Exclusion Criteria

  • progressive encephalopathy, treatment with multiple antiepileptic drugs, known genetic diagnosis.

Outcomes

Primary Outcomes

EEG and ERP abnormalities

Time Frame: 2 years

Secondary Outcomes

  • Characteristic and severity of autistic behaviors(2 years)

Investigators

Sponsor Class
Other

Study Sites (1)

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