OBJECTIVE Trigeminal nerve stimulation (TNS), a minimal-risk noninvasive neuromodulation method, showed potential benefits for attention-deficit/hyperactivity disorder (ADHD) in an unblinded open study. The present blinded sham-controlled trial was conducted to assess the efficacy and safety of TNS for ADHD and potential changes in brain spectral power using resting-state quantitative electroencephalography. METHOD Sixty-two children 8 to 12 years old, with full-scale IQ of at least 85 and Schedule for Affective Disorders and Schizophrenia-diagnosed ADHD, were randomized to 4 weeks of nightly treatment with active or sham TNS, followed by 1 week without intervention. Assessments included weekly clinician-administered ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales and quantitative electroencephalography at baseline and week 4. RESULTS ADHD-RS total scores showed significant group-by-time interactions (F1,228 = 8.12, p = .005; week 4 Cohen d = 0.5). CGI-Improvement scores also favored active treatment (χ21,168 = 8.75, p = .003; number needed to treat = 3). Resting-state quantitative electroencephalography showed increased spectral power in the right frontal and frontal midline frequency bands with active TNS. Neither group had clinically meaningful adverse events. CONCLUSION This study demonstrates TNS efficacy for ADHD in a blinded sham-controlled trial, with estimated treatment effect size similar to non-stimulants. TNS is well tolerated and has minimal risk. Additional research should examine treatment response durability and potential impact on brain development with sustained use. CLINICAL TRIAL REGISTRATION INFORMATION Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov/; NCT02155608.

中文翻译：

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三叉神经刺激治疗注意力缺陷/多动障碍的双盲、假对照初步研究。

目的 三叉神经刺激（TNS）是一种风险最小的无创神经调节方法，在一项非盲开放研究中显示出对注意力缺陷/多动障碍（ADHD）的潜在益处。目前进行的盲法假对照试验旨在评估 TNS 对 ADHD 的疗效和安全性，以及使用静息态定量脑电图对大脑光谱功率的潜在变化。方法 62 名 8 至 12 岁、全面智商至少为 85、情感障碍和精神分裂症诊断为 ADHD 的儿童被随机分配接受 4 周每晚接受主动或假 TNS 治疗，随后接受 1 周不接受主动或假 TNS 治疗。干涉。评估包括每周由临床医生实施的 ADHD 评定量表 (ADHD-RS) 和临床总体印象 (CGI) 量表以及基线和第 4 周的定量脑电图。结果 ADHD-RS 总分显示出显着的按时间分组的交互作用 (F1,228 = 8.12，p = .005；第 4 周 Cohen d = 0.5）。CGI 改善评分也支持积极治疗（χ21,168 = 8.75，p = .003；需要治疗的人数 = 3）。静息态定量脑电图显示，活动 TNS 时右额叶和额叶中线频段的频谱功率增加。两组均未发生有临床意义的不良事件。结论 这项研究在盲法假对照试验中证明了 TNS 对 ADHD 的疗效，估计治疗效果与非兴奋剂相似。TNS 耐受性良好且风险最小。其他研究应该检查治疗反应的持久性以及持续使用对大脑发育的潜在影响。临床试验注册信息 三叉神经刺激治疗多动症；http://clinicaltrials.gov/；NCT02155608。