Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reliable Change Index (RCI)on ADHD Rating Scale
研究概览
简要总结
The aim of this study is to investigate if electroencephalogram (EEG) biofeedback incorporating the use of video games is effective in improving inattentive symptoms in children with ADHD.
详细描述
This study will enroll 20 outpatient subjects aged 7 to 12 newly diagnosed with ADHD who have never received treatment with medication. These children should have inattentive symptoms, i.e. diagnosed with combined or inattentive subtype of ADHD, and should not have any of the exclusion criteria. Based on the gender ratios from other studies, we will enroll 8 boys and 2 girls into the intervention group, giving a male:female ratio of 4:1. 10 will be in the 'intervention' group and 10 in the 'control' group.
Informed consent will be obtained from the parents, and assent from the subjects, prior to any form of assessment or intervention as part of the study.
INTERVENTION
The 10 subjects in the intervention group will take part in a total of 20 sessions spread over a 10-week period. Each subject will first need to master a simple concentration task involving a fishing game. After this, the child will go on to play a second soccer game. Each game employs the BCI system, and is controlled by the child's concentration, which is fed to the computer via the EEG leads. The child watches the game on a computer screen. Each session may take approximately thirty minutes.
The other 10 children in the comparison group will act as controls. At the clinic visit at baseline assessment, they will play the fishing game. There will be no further intervention subsequently.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfy DSM-IV-TR criteria for ADHD (Combined OR Inattentive subtype)
排除标准
- •Present or history of medical treatment with stimulant medication and/or Atomoxetine
- •Co-morbid severe psychiatric condition or known sensori-neural deficit, e.g. complete blindness or deafness
- •History of epileptic seizures
- •Known mental retardation (i.e. IQ 70 and below)
- •Predominantly hyperactive/impulsive subtype of ADHD
研究组 & 干预措施
Intervention
20 sessions of EEG biofeedback training
干预措施: Brain-Computer Interface System (Device)
Control
Only 1 session of EEG biofeedback training
干预措施: Brain-Computer Interface System (Device)
结局指标
主要结局
Reliable Change Index (RCI)on ADHD Rating Scale
时间窗: week 0, 5, 10, 22
次要结局
- CBCL Attention Problem Score Change(Week 5, 10, 22)
研究者
Lim Choon Guan
Consultant
National Healthcare Group, Singapore