Neurofeedback Therapy for Children Diagnosed With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Changes in qEEG
研究概览
简要总结
This project aims:
- to further explore the effectiveness of a novel sonified Neurofeedback management therapy for children diagnosed with Autism Spectrum Disorder (ASD)
- to determine if balance control is different before and after therapy
详细描述
Once the informed consent of a parent or guardian has been secured, each child will be asked to provide informed assent. If the child elects to participate in the research project, he/she is enrolled in the study and assign to one of two groups: Active Comparator or Sham Comparator. If possible, his/her ability to maintain balance is then assessed using a standard extended mCTSIB protocol (standing for 25 seconds on a hard surface/4" tall foam cushion with eyes open/closed and head neutral/turned right/left/flexed or extended) and his/her baseline qEEG are recorded. A series of questionnaires will be administered to the child and/or his/her parents/legal guardian/caretaker.
Afterward the child will be instructed to wear the prescribed device (either the Active Comparator (Mente Autism™) or the Sham Comparator (a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats)) to use at home for 40 minutes a day for 12 weeks. At the end of the 12 weeks treatment period, the child will again be tested as at the beginning of the trial (posturography, qEEG, and questionnaires). At the end of the study, participants in the Sham Comparator group will be offered the option of receiving the full therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a clear diagnosis of ASD and a high starting delta wave level, as confirmed by the initial qEEG.
- •Furthermore, since the therapy is administered via a device requiring to be connected to a computer, tablet or phone with WiFi capabilities to work, the following are additional requirement:
- •iPhone 4s or later or all iPads except first generation iPAD running OS v7 or later, or
- •computer running Windows 7 or later
- •Tablet running Android 4.1 or later
- •Internet connection
排除标准
- •a history of hearing impairment and co-morbidities such as Rett-Syndrome and if they get low delta wave recordings in frontal lobe with qEEG (part of the baseline testing battery)
研究组 & 干预措施
Active
Children receiving Mente Autism™ neurofeedback therapy to use at home for 40 minutes a day for 12 weeks
干预措施: Mente Autism™ (Device)
Control
Children not receiving neurofeedback based therapy, but receiving the Sham therapy
干预措施: Sham (Device)
结局指标
主要结局
Changes in qEEG
时间窗: Baseline and at week 12
Changes will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much.
次要结局
- Changes in Stability Score(Baseline and at week 12)
- Changes in Social Responsiveness Scale (Second Edition) SRS-2(Baseline and at week 12)
- Changes in Autism Behaviour Checklist (ABC)(Baseline and at week 12)
- The Behavior Rating Inventory of Executive Function (BRIEF)(Baseline and at week 12)
- Changes in Questions about Behavioural Function (QABF) test(Baseline and at week 12)