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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2010 by Institute for Personal Excellence, P.A.
Sponsor:
Collaborators:
Life Quality Resources
Information provided by:
Institute for Personal Excellence, P.A.
ClinicalTrials.gov Identifier:
NCT01154777
First received: June 29, 2010
Last updated: October 3, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Autism
Behavioral: Neurofeedback training
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Institute for Personal Excellence, P.A.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Intervention Details:
    Behavioral: Neurofeedback training
    60 sessions of Neurofeedback on 6-18 year olds with Autism
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154777

Contacts
Contact: Magdalena M Wojdynska, M.D. 919-786-9700 magdalena@ipebraintraining.com
Contact: Lisa Ellis 919-786-9700 ext 4 lisae@ipebraintraining.com

Locations
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         
Sponsors and Collaborators
Institute for Personal Excellence, P.A.
Life Quality Resources
Investigators
Principal Investigator: Magdalena M Gebska-Wojdynska, M.D. Institute for Personal Excellence, P.A.
Principal Investigator: Lucy Chartier, Ph.D., NP Life Quality Resources
  More Information

Additional Information:
No publications provided

Responsible Party: Magdalena M. Gebska-Wojdynska, M.D., Institute for Personal Excellence, P.A
ClinicalTrials.gov Identifier: NCT01154777     History of Changes
Other Study ID Numbers: NFB6-18Autism
Study First Received: June 29, 2010
Last Updated: October 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Personal Excellence, P.A.:
Neurofeedback
Braintraining
Autism
Mild
Moderate
Mild to Moderate Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014