Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism - Full Text View

Sponsor:	Yellen & Associates, Inc.
Information provided by:	Yellen & Associates, Inc.
ClinicalTrials.gov Identifier:	NCT00693953

Purpose

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.

Condition
Autistic Disorder Autism, Early Infantile Autism, Infantile Asperger Syndrome

Study Type:	Observational
Study Design:	Case Control
Official Title:	Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism

Resource links provided by NLM:

MedlinePlus related topics: Asperger's Syndrome Autism

U.S. FDA Resources

Further study details as provided by Yellen & Associates, Inc.:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Year one
2 Year two

Detailed 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.

Eligibility

Ages Eligible for Study:	5 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693953

Locations

United States, California
Yellen & Associates, Inc.
Northridge, California, United States, 91326

Sponsors and Collaborators

Yellen & Associates, Inc.

Investigators

Principal Investigator:	Andrew G Yellen, PhD	President, Yellen & Associates, Inc.
Study Chair:	Thomas Schweller, MD	Neurologist

More Information

No publications provided

Responsible Party:	Yellen & Associates, Inc. ( Dr. Andrew G. Yellen )
Study ID Numbers:	PA-06-278
Study First Received:	June 5, 2008
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00693953 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yellen & Associates, Inc.:

Evoked Potentials
Evoked Potentials, Auditory
Evoked Potentials, Visual
Electroencephalography
Brain Mapping

Additional relevant MeSH terms:

Child Development Disorders, Pervasive
Pathologic Processes
Disease
Mental Disorders
Autistic Disorder

Syndrome
Mental Disorders Diagnosed in Childhood
Asperger Syndrome
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 30, 2009