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临床试验/NCT01154777
NCT01154777
Unknown
1 期

COLLABORATIVE STUDY OF NEUROFEEDBACK TRAINING OF 6-18YEAR OLDS WITH AUTISM

Institute for Personal Excellence, P.A.2 个研究点 分布在 1 个国家目标入组 30 人2011年7月
适应症Autism

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Autism
发起方
Institute for Personal Excellence, P.A.
入组人数
30
试验地点
2
主要终点
Level of normalization of brainwaves based upon QEEG
最后更新
15年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2011年7月
结束日期
2016年12月
最后更新
15年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Institute for Personal Excellence, P.A.

入排标准

入选标准

  • 6 to 18 year olds who have been diagnosed by their physician with mild to moderate autism, in accordance with DSM-IV diagnostic criteria

排除标准

  • 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.

结局指标

主要结局

Level of normalization of brainwaves based upon QEEG

时间窗: 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.

研究点 (2)

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