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

NCT ID: NCT01154777

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Autism

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Neurofeedback training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Life Quality Resources

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Institute for Personal Excellence, P.A.

OTHER

Sponsor Role lead

Responsible Party

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Institute for Personal Excellence, P.A

Principal Investigators

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Magdalena M Gebska-Wojdynska, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute for Personal Excellence, P.A.

Lucy Chartier, Ph.D., NP

Role: PRINCIPAL_INVESTIGATOR

Life Quality Resources

Locations

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Institute for Personal Excellence, P.A.

Raleigh, North Carolina, United States

Site Status

Life Quality Resources

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Magdalena M Wojdynska, M.D.

Role: CONTACT

[email protected]
919-786-9700

Lisa Ellis

Role: CONTACT

[email protected]
919-786-9700 ext. 4

Related Links

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http://www.lifequalityresources.org

Life Quality Resources

Other Identifiers

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NFB6-18Autism

Identifier Type: -

Identifier Source: org_study_id