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

Autism Clinical Trial

Official title:

COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH AUTISM

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01154777
• Other study ID #: NFB6-18Autism
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 29, 2010
• Last updated: October 3, 2010
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: October 2010
• Source: Institute for Personal Excellence, P.A.
• Contact: Magdalena M Wojdynska, M.D.
• Phone: 919-786-9700
• Email: magdalena[@]ipebraintraining.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Institute for Personal Excellence, P.A.	Raleigh	North Carolina
United States	Life Quality Resources	Raleigh	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Personal Excellence, P.A.	Life Quality Resources, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of normalization of brainwaves based upon QEEG	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.	Pre - training, 20 and 40 Session Interims, and post-training	No

External Links

•   Institute for Personal Excellence, P.A.
•   Life Quality Resources