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

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ClinicalTrials.gov Identifier: NCT01154777
Recruitment Status : Unknown
Verified October 2010 by Institute for Personal Excellence, P.A..
Recruitment status was:  Not yet recruiting
First Posted : July 1, 2010
Last Update Posted : October 5, 2010
Sponsor:
Collaborators:
Life Quality Resources
National Institute of Mental Health (NIMH)
Information provided by:
Institute for Personal Excellence, P.A.

Tracking Information
First Submitted Date  ICMJE June 29, 2010
First Posted Date  ICMJE July 1, 2010
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
Level of normalization of brainwaves based upon QEEG [ Time Frame: Pre - training, 20 and 40 Session Interims, and post-training ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01154777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism
Official Title  ICMJE COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE Behavioral: Neurofeedback training
60 sessions of Neurofeedback on 6-18 year olds with Autism
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 30, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154777
Other Study ID Numbers  ICMJE NFB6-18Autism
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Magdalena M. Gebska-Wojdynska, M.D., Institute for Personal Excellence, P.A
Study Sponsor  ICMJE Institute for Personal Excellence, P.A.
Collaborators  ICMJE
  • Life Quality Resources
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Magdalena M Gebska-Wojdynska, M.D. Institute for Personal Excellence, P.A.
Principal Investigator: Lucy Chartier, Ph.D., NP Life Quality Resources
PRS Account Institute for Personal Excellence, P.A.
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP