Collaborative Study Of Neurofeedback Training Of 6-18 Year 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH AUTISM|
- Level of normalization of brainwaves based upon QEEG [ Time Frame: Pre - training, 20 and 40 Session Interims, and post-training ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Behavioral: Neurofeedback training
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.
|Contact: Magdalena M Wojdynska, M.D.||firstname.lastname@example.org|
|Contact: Lisa Ellis||919-786-9700 ext email@example.com|
|United States, North Carolina|
|Institute for Personal Excellence, P.A.||Not yet recruiting|
|Raleigh, North Carolina, United States, 27607|
|Principal Investigator: Magdalena M. Gebska-Wojdynska, M.D.|
|Life Quality Resources||Not yet recruiting|
|Raleigh, North Carolina, United States, 27612|
|Principal Investigator: Lucy Chartier, Ph.D., NP|
|Principal Investigator:||Magdalena M Gebska-Wojdynska, M.D.||Institute for Personal Excellence, P.A.|
|Principal Investigator:||Lucy Chartier, Ph.D., NP||Life Quality Resources|