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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Institute for Personal Excellence, P.A..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154777
First Posted: July 1, 2010
Last Update Posted: October 5, 2010
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.
Collaborators:
Life Quality Resources
National Institute of Mental Health (NIMH)
Information provided by:
Institute for Personal Excellence, P.A.
June 29, 2010
July 1, 2010
October 5, 2010
July 2011
June 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01154777 on ClinicalTrials.gov Archive Site
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Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism
COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH AUTISM
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.
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.
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Autism
Behavioral: Neurofeedback training
60 sessions of Neurofeedback on 6-18 year olds with Autism
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
December 2016
June 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01154777
NFB6-18Autism
No
Not Provided
Not Provided
Magdalena M. Gebska-Wojdynska, M.D., Institute for Personal Excellence, P.A
Institute for Personal Excellence, P.A.
  • Life Quality Resources
  • National Institute of Mental Health (NIMH)
Principal Investigator: Magdalena M Gebska-Wojdynska, M.D. Institute for Personal Excellence, P.A.
Principal Investigator: Lucy Chartier, Ph.D., NP Life Quality Resources
Institute for Personal Excellence, P.A.
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP