ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- ADHD criteria according to the DSM-IV-TR rated by the investigator.
研究概览
简要总结
Background:
Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes. It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a scientific rigorously way and to study the underlying neurobiological mechanisms of EEG-neurofeedback.
Objectives:
- To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of ADHD.
- To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.
- To investigate whether EEG-neurofeedback is able to improve neural functioning.
Study design:
Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30 sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.
Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.
Hypothesis:
The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.
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
- •Diagnosis ADHD, classified by the (Diagnostic and Statistical Manual of Mental Disorders, 2000)
- •Age between 8 and 15
- •A full scale IQ of more than 80
- •Psychopharmaca- naïve or -free, or using a stable dosage of psychostimulants or atomoxetine but still with room for improvement (defined by an average score of more than 1 on ADHD-DSM-IV rating scale).
- •Deviant EEG of more than 1.5 standard deviation compared to the database
- •Exclusion criteria:
- •Currently intensive (i.e. weekly) individual or group psychotherapy
- •Regular use of medication other than psychostimulants or atomoxetine
- •Diagnosis of one or more of the following comorbid psychiatric disorders:
- •Major depression
- •Bipolar disorder
- •Psychotic disorder
- •Chronically motor tic disorder or Gilles de la Tourette
- •Conduct disorder
- •Autism spectrum disorders
- •Eating disorders
- •Neurological disorders (e.g. epilepsy) currently or in the past
- •Cardiovascular disease currently or in the past
- •Participation in another clinical trial simultaneously
- •EEG-neurofeedback training in the past
- •Use of alcohol or drugs
排除标准
- 未提供
结局指标
主要结局
ADHD criteria according to the DSM-IV-TR rated by the investigator.
时间窗: before, after 10, 20, 30 sessions and after half a year
次要结局
- side-effects by Score on the adapted Pittsburgh side effects rating scale(before, after 10, 20, 30 sessions)
研究者
Prof. Jan Buitelaar
professor dr.
Radboud University Medical Center