Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism
Primary Purpose
Autism
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback training
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Neurofeedback, Braintraining, Autism, Mild, Moderate, Mild to Moderate Autism
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.
Sites / Locations
- Institute for Personal Excellence, P.A.
- Life Quality Resources
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01154777
First Posted
June 29, 2010
Last Updated
October 3, 2010
Sponsor
Institute for Personal Excellence, P.A.
Collaborators
Life Quality Resources, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01154777
Brief Title
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
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Institute for Personal Excellence, P.A.
Collaborators
Life Quality Resources, National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Neurofeedback, Braintraining, Autism, Mild, Moderate, Mild to Moderate Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback training
Intervention Description
60 sessions of Neurofeedback on 6-18 year olds with Autism
Primary Outcome Measure Information:
Title
Level of normalization of brainwaves based upon QEEG
Description
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.
Time Frame
Pre - training, 20 and 40 Session Interims, and post-training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena M Wojdynska, M.D.
Phone
919-786-9700
Email
magdalena@ipebraintraining.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Ellis
Phone
919-786-9700
Ext
4
Email
lisae@ipebraintraining.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena M Gebska-Wojdynska, M.D.
Organizational Affiliation
Institute for Personal Excellence, P.A.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucy Chartier, Ph.D., NP
Organizational Affiliation
Life Quality Resources
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Personal Excellence, P.A.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena M. Gebska-Wojdynska, M.D.
Facility Name
Life Quality Resources
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Chartier, Ph.D., NP
12. IPD Sharing Statement
Links:
URL
http://www.lifequalityresources.org
Description
Life Quality Resources
Learn more about this trial
Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism
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