Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.
Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.
J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):856-864.e1. doi: 10.1016/j.jaac.2020.09.021. Epub 2020 Oct 15.
The current study applies a precision medicine approach to trigeminal nerve simulation (TNS), a Food and Drug Administration-approved neuromodulation treatment for attention-deficit/hyperactivity disorder (ADHD), by testing secondary outcomes of cognitive and electroencephalographic [EEG] predictors of treatment response among subjects from the original randomized controlled trial.
Children aged 8 to 12 years with ADHD, were randomized to 4 weeks of active or sham TNS treatment, after which the sham group crossed over into 4 weeks of open-label treatment. TNS treatment responders (RESP) had an ADHD Rating Scale (ADHD-RS) Total score reduction of ≥25%, whereas nonresponders (NR) had <25% reduction posttreatment. Assessments included weekly behavioral ratings and pre-/posttreatment cognitive EEG measures.
The final sample was 25 RESP and 26 NR comprising 34 male and 17 female children, with a mean (SD) age of 10.3 (1.4) years. Baseline measures that significantly differentiated RESP from NR included: lower working memory, lower spelling and mathematics achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p values <.05). Compared to NRs, responders showed significantly increased right frontal EEG power with TNS treatment, which was predictive of improved executive functions and ADHD symptomatology (β = 0.65, p < .001). When EEG findings and behavior were modeled together, the area under the curve (AUC) for BRIEF Working Memory scale was 0.83 (p = .003), indicating moderate prediction of treatment response.
Children with ADHD who have executive dysfunction are more likely to be TNS responders and show modulation of right frontal brain activity, improved/normalized executive functions, and ADHD symptom reduction.
Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov; NCT02155608.
本研究通过测试认知和脑电图[EEG]预测因子的次要结果，应用精准医学方法对三叉神经刺激（TNS）进行研究，TNS 是一种经美国食品和药物管理局批准的用于治疗注意缺陷多动障碍（ADHD）的神经调节治疗方法，该研究纳入了原始随机对照试验中的受试者。
8 至 12 岁的 ADHD 儿童被随机分为 4 周的 TNS 治疗组或假刺激治疗组，之后假刺激组交叉进入 4 周的开放标签治疗。TNS 治疗反应者（RESP）的 ADHD 评定量表（ADHD-RS）总分降低≥25%，而无反应者（NR）治疗后降低<25%。评估包括每周行为评分和治疗前后认知 EEG 测量。
最终样本包括 25 名 RESP 和 26 名 NR，共 34 名男性和 17 名女性儿童，平均（SD）年龄为 10.3（1.4）岁。区分 RESP 和 NR 的基线测量包括：较低的工作记忆、较低的拼写和数学成绩、执行功能行为评定量表（BRIEF）的执行功能缺陷以及右额区（F4）静息状态 EEG 功率较低（所有 p 值均<.05）。与 NR 相比，反应者在 TNS 治疗后右额 EEG 功率显著增加，这与执行功能改善和 ADHD 症状减轻有关（β=0.65，p<.001）。当将 EEG 发现和行为一起建模时，BRIEF 工作记忆量表的曲线下面积（AUC）为 0.83（p=0.003），表明对治疗反应有中等程度的预测。
有执行功能障碍的 ADHD 儿童更有可能成为 TNS 反应者，并且表现出右额大脑活动的调节、执行功能的改善/正常化以及 ADHD 症状的减轻。
ADHD 的外部三叉神经刺激发育性初步研究；http://clinicaltrials.gov；NCT02155608。
