NCT00693953

Brief Summary

Individuals with Autism Spectrum Disorder will have abnormal DESA® results. Our objective is to use neuroelectrical measures to determine the degree of processing abnormalities in individuals with Autism. The study will survey processing patterns and will locate and evaluate the degree(s) of abnormalities for further study. The abnormal results of comprehensive neuroelectrical evaluations of individuals with Autism when compared to the normative database will provide objective, verifiable, neurophysiological information with which to form novel approaches to the disorder.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

June 5, 2008

Last Update Submit

October 1, 2009

Conditions

Keywords

Evoked PotentialsEvoked Potentials, AuditoryEvoked Potentials, VisualElectroencephalographyBrain Mapping

Study Arms (2)

1

Year one

2

Year two

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population includes individuals with Autism without exclusion on the basis of sex, gender, race or ethnicity. There will be 100 research subjects, with a ratio of four males to one female, and those being approximately sixty-five children and thirty-five adults.

You may qualify if:

  • The study will include children between the ages of five and eighteen, adults from the age of nineteen to twenty-five, and those with the diagnosis of Autism and Autism Spectrum Disorders.

You may not qualify if:

  • those with mental retardation
  • those with any other neurological disorder
  • those that cannot sit in a chair for one hundred and fifty minutes
  • those that have been previously diagnosed with a seizure disorder
  • those who are blind and/or deaf
  • those who are not ambulatory
  • those who cannot understand English
  • those that are not a resident of Los Angeles County

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yellen & Associates, Inc.

Northridge, California, 91326, United States

Location

MeSH Terms

Conditions

Autistic DisorderAsperger Syndrome

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Andrew G Yellen, PhD

    President, Yellen & Associates, Inc.

    PRINCIPAL INVESTIGATOR
  • Thomas Schweller, MD

    Neurologist

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 9, 2008

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

December 1, 2012

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations