Collaborative Study Of Neurofeedback Training Of 6-18 Year Olds With Autism
COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH AUTISM
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2011
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 5, 2010
October 1, 2010
4.9 years
June 29, 2010
October 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Pre - training, 20 and 40 Session Interims, and post-training
Interventions
60 sessions of Neurofeedback on 6-18 year olds with Autism
Eligibility Criteria
You may qualify if:
- to 18 year olds who have been diagnosed by their physician with mild to moderate autism, in accordance with DSM-IV diagnostic criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute for Personal Excellence, P.A.lead
- Life Quality Resourcescollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Institute for Personal Excellence, P.A.
Raleigh, North Carolina, 27607, United States
Life Quality Resources
Raleigh, North Carolina, 27612, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena M Gebska-Wojdynska, M.D.
Institute for Personal Excellence, P.A.
- PRINCIPAL INVESTIGATOR
Lucy Chartier, Ph.D., NP
Life Quality Resources
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 1, 2010
Study Start
July 1, 2011
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
October 5, 2010
Record last verified: 2010-10