Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD

三叉神经外刺激治疗多动症的疗效

• 批准号: 10431653
• 负责人: Sandra K Loo
• 金额: $ 81.27万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-12 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10431653
• 关键词: 12 year old; Address; Age; Attention deficit hyperactivity disorder; Behavior Disorders; Behavioral; Biological Markers; Brain; Caring; Characteristics; Child; Clinical; Cognitive; Communities; Consumption; Data; Development; Devices; Double-Blind Method; Effectiveness; Electroencephalogram; Ensure; Exhibits; Family; Frequencies; Functional disorder; Gold; High Prevalence; Home; Individual; Intervention; Literature; Measurement; Mediating; Mediator of activation protein; Methods; Minority; National Institute of Mental Health; Outcome; Parents; Parietal; Patients; Pharmaceutical Preparations; Pilot Projects; Prediction of Response to Therapy; Psychiatry; Quality of life; Randomized; Randomized Clinical Trials; Research; Research Institute; Research Priority; Research Support; Rest; Sample Size; Sampling; Short-Term Memory; Site; Sleep; Symptoms; Targeted Research; Testing; Time; Trigeminal nerve structure; Validation; Youth; aged; attentional control; base; burden of illness; clinical heterogeneity; cognitive function; confirmatory trial; cost; cost effective; efficacious intervention; efficacious treatment; efficacy testing; follow-up; impression; improved; indexing; informant; innovation; metacognition; minimal risk; neuromechanism; neuroregulation; non-compliance; novel; personalized medicine; placebo group; predicting response; primary outcome; prospective; psychostimulant; reduce symptoms; response; secondary outcome; side effect; societal costs; standard care; teacher; treatment arm; treatment effect; treatment response; treatment strategy

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.

项目总结/摘要 注意力缺陷多动障碍（ADHD）患病率高（4-17岁儿童的5-11%）， 再加上其高昂的社会成本、强大的持久性和对生活质量的有害影响， 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 一个主要挑战，可能与多种因果路径相关，并导致临床表现的变异性， 潜在的神经机制和治疗反应。虽然精神兴奋剂是治疗的黄金标准， 治疗ADHD，次优反应，不良副作用和不遵守的问题发生在一个 少数患有ADHD的人。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 ADHD（和一般精神病学）的干预措施，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治疗方法是否对给定的患者有效的能力， 对于专业人员和患者来说，个体化是昂贵和耗时的，并且由于 举报人之间的分歧在本项目中，我们将进行一项大型多中心随机临床试验， 测试外部三叉神经刺激（TNS）的疗效，这是一种新型的，风险最小的，非侵入性的 神经调节治疗，用于7-12岁儿童的ADHD（N=180）。这一影响深远的项目将 为ADHD的药物支持非药物干预文献做出了重大贡献， 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子 反应证明TNS对ADHD的疗效可以为数百万家庭提供一种可行的非 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 在这项研究的支持下。对行为特征的验证可显著预测治疗 反应将使识别适合TNS治疗的患者变得简单且极具成本效益 以及加强向社区传播治疗方法。这一建议与几个NIMH一致 优先事项，包括制定创新的干预措施，评估 有效干预大脑和识别行为和认知特征，以指导 治疗方法。