Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD

项目摘要/摘要 注意力缺陷/多动障碍(ADHD)的高患病率(4-17岁儿童中5%-11%)， 再加上它的高社会成本，强烈的持久性和对生活质量的有害影响，保证继续 努力了解其潜在的神经机制并找到有效的治疗方法。临床异质性是 一个主要的挑战，可能与多种因果路径有关，并导致临床表现的可变性， 潜在的神经机制和治疗反应。尽管精神刺激剂是 对于ADHD的治疗，出现反应不佳、副作用和不依从的问题 患有ADHD的人中有相当一部分人。因此，迫切需要有经验支持的非 ADHD的药物干预。此外，预测治疗反应的可靠方法 对ADHD(和一般的精神病学)的干预，包括药物和非药物方法， 仍然难以捉摸。这种无法前瞻性地预测一种治疗方法是否对给定的 对于专业人员和患者来说，单独使用是昂贵和耗时的，而且通常由于以下原因而无法确定 告密者之间的分歧。在这个项目中，我们将进行一项大型、多点随机临床试验，以 测试外三叉神经刺激(TNS)的疗效，这是一种新的、低风险、无创的方法 神经调节治疗，治疗7-12岁儿童ADHD(N=180)。这个影响很大的项目将 对ADHD的经验性非药物干预的文献有重大贡献， 确定潜在的神经机制，并测试临床上有用的行为和认知治疗预测因素 回应。证实TNS治疗ADHD的有效性可以为数百万家庭提供可行的非 药物治疗选择，在某些情况下，作为ADHD患者的一线治疗策略，如果 由这项研究支持。对治疗有显著预测作用的行为特征的验证 响应将使识别适合TNS治疗的患者变得简单且极具成本效益 以及加强治疗在社区中的传播。这一建议与几个NIMH一致 优先事项，包括制定创新干预措施、评估联合国系统的行动机制 对大脑进行有效的干预，并确定行为和认知特征以指导 治疗方法正在接近。

Project Summary/Abstract High prevalence rates of attention-deficit/ hyperactivity disorder (ADHD) (5-11% of children 4-17 years), combined with its high societal cost, strong persistence and pernicious effects on quality of life, warrant continued efforts to understand its underlying neural mechanisms and find efficacious treatments. Clinical heterogeneity is a major challenge, likely related to multiple causal paths, and contributes to variability in clinical presentation, underlying neural mechanisms, and treatment response. Although psychostimulants are the gold standard of treatment for ADHD, problems with suboptimal response, adverse side effects and non-compliance occur for a significant minority of those with ADHD. As a result, there is a critical need for empirically supported non- pharmacological interventions for ADHD. In addition, a reliable method for predicting response to treatment interventions in ADHD (and psychiatry in general), both medication and non-pharmacological approaches alike, remains elusive. This inability to prospectively predict whether a treatment approach will be effective for a given individual is costly and time consuming for professionals and patients, and often inconclusive due to disagreement between informants. In this project, we will conduct a large, multisite randomized clinical trial to test the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, non-invasive neuromodulation treatment, for ADHD in children ages 7-12 years old (N=180). This high impact project will contribute significantly to the literature for empirically-supported nonpharmacological interventions for ADHD, identify underlying neural mechanisms, and test clinically useful behavioral and cognitive predictors of treatment response. Confirming the efficacy of TNS for ADHD could provide millions of families a viable non- pharmacological treatment option, and in some cases, as first-line treatment strategy for patients with ADHD, if supported by this research. The validation of a behavioral profile that is significantly predictive of treatment response will make identification of patients appropriate for TNS treatment simple and extremely cost effective as well as enhance dissemination of treatment into the community. This proposal is consistent with several NIMH priorities, including the development of innovative interventions, assessment of the mechanisms of action of efficacious interventions in the brain and identification of behavioral and cognitive characteristics to guide treatment approaches.