Comparative Clinical Trial With Double-blind Randomized Sham Control and Additive Treatment Toward Efficacy of Mobile Neurofeedback for ADHD Youth : An Exploratory Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Korean Attention Deficit Hyperactivity Disorder rating scale
研究概览
简要总结
Objective: Verification of ADHD Treatment Effectiveness of Mobile Neurofeedback to Subjects of Child and Youth with ADHD.
Method: Mobile Neurofeedback Program is implemented for 165 ADHD patients aged 8 to 15 to verify their effectiveness by conducting pre-post evaluation. Prior to the implementation of the intervention, we conduct a survey with demographic information, behavioral characteristics, clinical global impression, neuropsychological test, brain MRI, NIRS and EEG.
The drug naive subjects are randomly assigned to the mobile Neurofeedback group or Sham control group. The subjects on medication are randomly assigned to the mobile Neurofeedback group or Sham control group, In addition to the medication being administered.
The intervention are conducted three times a week, twice a day, and 10-20 minutes for 12 weeks, and the effectiveness is assessed four times in advance, third month, sixth month and twelfth months.
However, the Sham control group were provided the same machines and programs as the Neurofeedback exercise, but feedback is generated randomly regardless of ectroencephalogram change of the subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient between the ages of 8 and 15
- •Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria and K-SADS-PL ③ IQ 80 or higher ④ Neurofeedback or Sham treatment group include patients who have not received methylphenidate/atomoxetine medication in the past or who have been treated with methylphenidate less than a year and not taken methylphenidate/atomoxetine within four weeks of starting point of this study.
- •medication+Neurofeedback or medication+Sham treatment group include ADHD patients undergoing methylphenidate or atomoxetine medication over the past month without changes in capacity. And ADHD patients whose CGI-S scale is 4 or higher.
排除标准
- •Patients diagnosed with congenital genetic disease
- •Patients with a clear history of acquired brain damage, such as cerebral palsy. ③ Patients with convulsions, other neurological disorders, or uncorrected sensory disorders
- •Patients with a history of schizophrenia, other childhood psychosis ⑤ IQ below 80 ⑥ Patient with obsessive compulsive disorder, major depression or bipolar disorder
结局指标
主要结局
Korean Attention Deficit Hyperactivity Disorder rating scale
时间窗: twelfth month
Clinical Global Impression Scale-Severity
时间窗: twelfth month
Children's Global Assessment Scale
时间窗: twelfth month
次要结局
- brain MRI(at the beginning, third month, sixth month, twelfth month)
- EEG power in beta band(at the beginning, third month, sixth month, twelfth month)
- EEG power in theta band(at the beginning, third month, sixth month, twelfth month)
- Near Infra-Red Spectroscopy(at the beginning, third month, sixth month, twelfth month)
研究者
Booog Nyung Kim
Professor
Seoul National University Childrens Hospital