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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01154777
Enrollment
30
Registered
2010-07-01
Start date
2011-07-31
Completion date
2016-12-31
Last updated
2010-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

Neurofeedback, Braintraining, Autism, Mild, Moderate, Mild to Moderate Autism

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.

Interventions

60 sessions of Neurofeedback on 6-18 year olds with Autism

Sponsors

Life Quality Resources
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Institute for Personal Excellence, P.A.
Lead SponsorOTHER

Study design

Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Level of normalization of brainwaves based upon QEEGPre - training, 20 and 40 Session Interims, and post-trainingAfter 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.

Countries

United States

Contacts

Primary ContactMagdalena M Wojdynska, M.D.
magdalena@ipebraintraining.com919-786-9700
Backup ContactLisa Ellis
lisae@ipebraintraining.com919-786-9700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026