Pilot Explorations of Neurofeedback Issues in ADHD

描述（由申请人提供）：神经反馈（EEG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），尽管证据基础薄弱。许多开放和部分对照研究存在严重的设计缺陷，特别是缺乏盲法和罕见的随机化。特别是，没有发表的双盲随机临床试验（RCT）。该R34中试申请的主要目的是通过解决几个可行性/有效性/适口性问题（这些问题将决定适当的设计）为此类RCT做准备。这些包括治疗的频率和次数以及新技术设盲的可行性。次要目的包括使用改进的盲法技术复制先前研究中发现的效应量（d>0.7），并探索年龄、性别和ADHD亚型的效应。36名年龄在6-12岁的男孩和女孩，患有严格诊断的DSM-IV ADHD，目前没有服用药物，将被随机分为两组：第一组为主动神经反馈（n=24）与假神经反馈（n=12），同时每周2次与3次治疗频率（每个频率18次，12次主动和6次假），共40次治疗。在治疗24时，主要评估将包括满意度和设盲指标，受试者将可选择在剩余16次治疗中转换为相反的治疗频率，以产生方案适口性的实际指标。主要评估（基线、治疗12、治疗24、治疗40和随访时）将包括症状、功能障碍、学习成绩/成就的测量以及注意力、警惕性和执行功能的神经心理学测试。每3次治疗，家长将评估ADHD症状，每6次治疗，教师将评估，以跟踪随时间变化的反应曲线。基线EEG觉醒和ADHD亚型将作为可能的调节因子进行检查。通过确定治疗的最佳频率和数量，并证明双盲的可行性，这项初步研究应该为神经反馈的确定性大型RCT铺平道路。注意力缺陷多动障碍（Attention Deficit/Hyperactivity Disorder，ADHD）是最常见的儿童精神障碍，对儿童的学业、社会/婚姻、职业功能甚至安全都有重要影响。由于目前已确立的治疗方法对近一半的患者来说不是最佳的，许多人拒绝最有效的治疗方法（兴奋剂药物），因此有大量的公共卫生需求，需要额外的治疗选择，如神经反馈（EEG生物反馈），这是令人鼓舞的初步开放和部分对照研究，但没有发表双盲研究。由于其费用和劳动强度，需要进行严格的测试，本申请是对这一需求的回应，提出了一项试点研究，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.