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Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01154777
Recruitment Status : Unknown
Verified October 2010 by Institute for Personal Excellence, P.A..
Recruitment status was:  Not yet recruiting
First Posted : July 1, 2010
Last Update Posted : October 5, 2010
Life Quality Resources
National Institute of Mental Health (NIMH)
Information provided by:
Institute for Personal Excellence, P.A.

Brief Summary:
Neurofeedback, a neuro-cognitive training method based on operant conditioning, will be employed with 90 children with the Autistic Spectrum Disorders (ASD) over a 60 session training period to improve the limiting behavioral and sensory symptoms Autism presents (with each collaborative site working with 45 of the 90 participants). This study seeks to demonstrate that Neurofeedback training, a non-invasive approach based on Learning Theory, will mitigate presenting symptoms of Autism, and ultimately render the person with Autism significantly more able to interact with his/her environment successfully, independently function on a day-to-day basis, and improve overall mental health.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Neurofeedback training Phase 1

Detailed Description:
The specific objective is to demonstrate quantitative and qualitative improvements in functional and behavioral parameters in individuals affected by Autism Spectrum Disorders when 60 Neurofeedback training sessions are applied. The long term objectives for these individuals include improvement of quality of daily functioning, better ability to integrate and navigate within society, and overall to decrease the limitations caused by the disability. Additionally, increasing awareness by the public, as well as healthcare providers and legislation, that Neurofeedback is a viable intervention which may contribute not only to a significant reduction of the level of disability for affected individuals, but also in reducing required lifetime costs of healthcare. Hopefully in the future Neurofeedback training would be incorporated as a standard of care for ASD. As of today, there are around 1000 trained Neurofeedback practitioners in the US who are offering this intervention to a very limited number of individuals due to lack of recognition of NFB benefits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2011
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Intervention Details:
  • Behavioral: Neurofeedback training
    60 sessions of Neurofeedback on 6-18 year olds with Autism

Primary Outcome Measures :
  1. Level of normalization of brainwaves based upon QEEG [ Time Frame: Pre - training, 20 and 40 Session Interims, and post-training ]
    After completion of all neurofeedback sessions, post-training evaluation will include cognitive testing, completion of ASRS and ATEC forms and a post-QEEG. Interviews with parents will also be conducted to identify progress and changes in symptom presentation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 6 to 18 year olds who have been diagnosed by their physician with mild to moderate autism, in accordance with DSM-IV diagnostic criteria

Exclusion Criteria:

  • Any child with a diagnosis of Bipolar Disorder, Tourette's Syndrome, an uncontrolled seizure disorder, or a history of any major psychiatric disorder will be excluded from eligibility for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01154777

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Contact: Magdalena M Wojdynska, M.D. 919-786-9700
Contact: Lisa Ellis 919-786-9700 ext 4

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United States, North Carolina
Institute for Personal Excellence, P.A.
Raleigh, North Carolina, United States, 27607
Principal Investigator: Magdalena M. Gebska-Wojdynska, M.D.         
Life Quality Resources
Raleigh, North Carolina, United States, 27612
Principal Investigator: Lucy Chartier, Ph.D., NP         
Sponsors and Collaborators
Institute for Personal Excellence, P.A.
Life Quality Resources
National Institute of Mental Health (NIMH)
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Principal Investigator: Magdalena M Gebska-Wojdynska, M.D. Institute for Personal Excellence, P.A.
Principal Investigator: Lucy Chartier, Ph.D., NP Life Quality Resources
Additional Information:
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Responsible Party: Magdalena M. Gebska-Wojdynska, M.D., Institute for Personal Excellence, P.A Identifier: NCT01154777    
Other Study ID Numbers: NFB6-18Autism
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: October 5, 2010
Last Verified: October 2010
Keywords provided by Institute for Personal Excellence, P.A.:
Mild to Moderate Autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders