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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00693953
Other study ID # PA-06-278
Secondary ID
Status Withdrawn
Phase N/A
First received June 5, 2008
Last updated October 1, 2009
Start date January 2010
Est. completion date December 2012

Study information

Verified date October 2009
Source Yellen & Associates, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

The research method will be: gathering, analyzing and utilizing data.

We will observe research subjects through neuroelectrical instrumentation, then, compare results to retrospective information collected from research subjects and a normative database.

A qualified neurologist thoroughly familiar with electrophysiology will interpret the data, and analyze it to explore the abnormalities.

The hypothesis will be evaluated.

We will, then, utilize the results to find data-based forms of treatment for those with the disorder.


Recruitment information / eligibility

Status Withdrawn
Enrollment 200
Est. completion date December 2012
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 25 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Observational Model: Case Control


Locations

Country Name City State
United States Yellen & Associates, Inc. Northridge California

Sponsors (1)

Lead Sponsor Collaborator
Yellen & Associates, Inc.

Country where clinical trial is conducted

United States, 

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