NCT00319722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 4, 2010

Status Verified

May 1, 2010

Enrollment Period

5.1 years

First QC Date

April 27, 2006

Last Update Submit

May 3, 2010

Conditions

Autism

Keywords

autismpervasive developmental disorderevoked potentialsEEGCoherence

Outcome Measures

Primary Outcomes (1)

  • EEG and ERP abnormalities

    2 years

Secondary Outcomes (1)

  • Characteristic and severity of autistic behaviors

    2 years

Eligibility Criteria

Age3 Months - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

autistic children meeting criteria for autism based on ADOS and ADI and clinical DSM IV or their siblings between the ages of 3 months to 13 years.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH LADDERS Clinic

Lexington, Massachusetts, 02421, United States

RECRUITING

MeSH Terms

Conditions

Autistic DisorderChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental DisordersMental Disorders

Study Officials

  • Katherine M. Martien, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Martha Herbert, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Orinstein

CONTACT

617-966-9766transcend@partners.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 4, 2010

Record last verified: 2010-05

Locations

US(1)