Clinical trial NCT01154777: Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism
Official title: COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH AUTISM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Autism
Keywords: Neurofeedback
Braintraining
Autism
Mild
Moderate
Mild to Moderate Autism
Lead sponsor: Institute for Personal Excellence, P.A.
Sponsor class: OTHER
Collaborators: name: Life Quality Resources
name: National Institute of Mental Health (NIMH)
First posted: 2010-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Level of normalization of brainwaves based upon QEEG
timeFrame: Pre - training, 20 and 40 Session Interims, and post-training
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Institute for Personal Excellence, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: Life Quality Resources
state: North Carolina
Study officials:
affiliation: Institute for Personal Excellence, P.A.
name: Magdalena M Gebska-Wojdynska, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Life Quality Resources
name: Lucy Chartier, Ph.D., NP
role: PRINCIPAL_INVESTIGATOR
References: