A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy
A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy
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DOI：
10.1177/1087054713482580
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发表时间：
2013-07-01
影响因子：
3
通讯作者：
Monastra, Vince
中科院分区：
文献类型：
--
作者：
Arnold, L. Eugene;Arns, Martijn;Monastra, Vince
目的：ADHD需要持续获益的额外治疗。由于ADHD经常表现出过度的θ脑电图（EEG）功率，低β和过度的θ-β比率（TBR），一种有希望的治疗方法是神经反馈（NF）下训练TBR。虽然一些非盲随机临床试验（RCT）显示NF的中-大获益，但需要一个良好的盲法、假对照RCT来区分特异性和非特异性效应。方法：NF、ADHD、临床试验和统计学方面的专家合作设计了一项双盲多中心RCT。结果/结论：在四个研究中心，180名7 - 10岁的儿童被严格诊断为ADHD，TBR >= 5，将被随机分为活动TBR-NF组和假NF组，时间、强度和外观相同。假的，利用预先记录的脑电图与参与者的文物叠加，将保持参与者和工作人员盲目。治疗保真度将由公认的NF领导人进行培训/监测。治疗前、治疗期间和治疗后（随访至2年）的多领域评估还将包括设盲和假手术惰性试验。
Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large benefit for NF, a well-blinded, sham-controlled RCT is needed to differentiate specific from nonspecific effects. Method: Experts in NF, ADHD, clinical trials, and statistics collaborated to design a double-blind multisite RCT. Results/Conclusion: At four sites, 180 children aged 7 to 10 years with rigorously diagnosed ADHD and TBR >= 5 will be randomized to active TBR-NF versus sham NF of equal duration, intensity, and appearance. Sham, utilizing prerecorded EEGs with participant artifacts superimposed, will keep participants and staff blind. Treatment fidelity will be trained/monitored by acknowledged NF leaders. Multidomain assessments before, during, and after treatment (follow-up to 2 years) will also include tests of blinding and sham inertness.