Autistic DisorderNCT00693953
Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism
An observational study of Autistic Disorder and Autism, Early Infantile, run by Yellen & Associates, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Autistic Disorder, Autism, Early Infantile, Autism, Infantile
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yellen & Associates, Inc.
Northridge, California, 91326
About this study
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.
Read the 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.
- Keywords
- Evoked Potentials, Evoked Potentials, Auditory, Evoked Potentials, Visual, Electroencephalography, Brain Mapping
- Medical subject headings
- Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Year one | |
| 2 | Year two |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: grant was not approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yellen & Associates, Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Andrew G Yellen, PhD, Principal investigator, President, Yellen & Associates, Inc.Thomas Schweller, MD, Study chair, Neurologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693953
- Sponsor's protocol ID
- PA-06-278
- Status last verified
- Oct 2009
- First submitted
- 5 Jun 2008
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Digital EEG Spectral Analysis in Assessing Neuroelectrical Processing Abnormalities in Autism
- ClinicalTrials.gov ID
- NCT00693953
- Acronym / sponsor ID
- PA-06-278
- Keywords
- Evoked Potentials, Evoked Potentials, Auditory, Evoked Potentials, Visual, Electroencephalography, Brain Mapping
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: grant was not approved.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yellen & Associates, Inc.University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Year one |
| 2 | – | –Year two |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew G Yellen, PhD principal investigator
President, Yellen & Associates, Inc.
Thomas Schweller, MD study chair
Neurologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder and Autism, Early Infantile, run by Yellen & Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2009.