Pilot Explorations of Neurofeedback Issues in ADHD

描述(申请人提供)：神经反馈(脑电生物反馈)越来越多地被提倡用于治疗注意力缺陷/多动障碍(ADHD)，尽管证据基础很薄。许多开放的和部分对照的研究存在严重的设计缺陷，特别是缺乏盲目性和罕见的随机性。特别是，目前还没有公开的双盲随机临床试验(RCT)。R34试点应用的主要目的是通过解决几个决定适当设计的可行性/效率/适宜性问题来为这样的RCT做准备。这些问题包括治疗的频率和次数，以及使用新技术致盲的可行性。次要目标包括用改进的盲法复制先前研究中发现的效应大小(d&gt；0.7)，并探索年龄、性别和ADHD亚型的效应。36名6-12岁患有严格诊断为DSM-IV ADHD的男孩和女孩将被随机分为两组：第一组为主动神经反馈(n=24)，另一组为假神经反馈(n=12)，同时每周治疗频率为2次与3次(每个频率18次，12次活跃，6次虚假)，共40次。在24号治疗中，主要评估将包括满意度和失明程度的衡量，受试者将被允许选择在其余16个治疗中切换到相反的治疗频率，以产生时间表适宜性的实际衡量标准。主要评估(基线、治疗12、治疗24、治疗40和后续)将包括症状、功能障碍、学习成绩/成就的测量，以及注意力、警觉性和执行功能的神经心理测试。每3次治疗，家长会对ADHD症状进行评分，老师会对每6次治疗进行评分，以跟踪随着时间的推移的反应曲线。基线脑电唤醒和ADHD亚型将被检查为可能的调节因素。通过确定最佳治疗频率和治疗次数，并证明双盲治疗的可行性，这项先导性研究应该为神经反馈的最终大规模随机对照试验铺平道路。注意力缺陷多动障碍(ADHD)是最常见的儿童精神障碍，严重影响学习、社会、婚姻、职业功能，甚至影响安全。由于目前已建立的治疗方法对几乎一半的患者来说不是最理想的，许多人拒绝了最有效的治疗方法(兴奋剂药物)，因此公共卫生需要更多的治疗选择，如神经反馈(EEG生物反馈)，它有令人鼓舞的初步开放和部分对照研究，但没有发表的双盲研究。由于其费用和劳动强度，需要严格的测试，而这一应用正是针对这种需求，提出了一项先导性研究，以解决一些可行性和设计问题，为大型双盲随机试验做准备。

DESCRIPTION (provided by applicant): Neurofeedback (EEG biofeedback) is increasingly advocated for treatment of attention-deficit/hyperactivity disorder (ADHD) despite a thin evidence base. The numerous open and partially controlled studies suffer serious design flaws, especially lack of blinding and rare randomization. In particular, there is no published double-blind randomized clinical trial (RCT). The primary aim of this R34 pilot application is to prepare for such a RCT by resolving several feasibility/efficiency/palatability issues that would determine appropriate design. These include the frequency and number of treatments and feasibility of blinding with new technology. Secondary aims include to replicate, with an improved blinding technique, the effect sizes (d>0.7) found in prior studies and to explore age, sex, and ADHD subtype effects. Thirty-six boys and girls aged 6-12 with rigorously diagnosed DSM-IV ADHD not currently taking medication will be twice-randomized: first to active neurofeedback (n=24) vs. sham neurofeedback (n=12), and simultaneously to 2 vs. 3 times a week treatment frequency (18 in each frequency, 12 active and 6 sham) for 40 treatments. At treatment 24, major assessments will include measures of satisfaction and blinding, and subjects will be given the option of switching to the opposite treatment frequency for the remaining 16 treatments to generate a practical measure of schedule palatability. Major assessments (at baseline, treatment 12, treatment 24, treatment 40, and follow-up) will include measures of symptoms, functional impairment, academic performance/achievement, and neuropsychological tests of attention, vigilance, and executive functioning. Every 3 treatments parents will rate ADHD symptoms and every 6 treatments teachers will rate, to track the response curve over time. Baseline EEG arousal and ADHD subtype will be examined as possible moderators. By determining the optimal frequency and number of treatments and demonstrating feasibility of double blinding, this pilot study should pave the way for a definitive large RCT of neurofeedback. Attention-deficit/hyperactivity disorder (ADHD) is the most common child mental disorder, with significant impact on academic, social/marital, and occupational function, and even on safety. Because current established treatments are less than optimal for almost half of patients and many decline the most effective ones (stimulant medication), there is a large public health need for additional treatment options such as neurofeedback (EEG biofeedback), which has encouraging preliminary open and partially controlled studies but no published double-blind studies. Because of its expense and laborious intensity, rigorous testing is needed, and this application is in response to that need, proposing a pilot study to resolve some feasibility and design issues preparatory to a large double-blind randomized trial.