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: 10609060
• 负责人: Sandra K Loo
• 金额: $ 75.36万
• 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/10609060
• 关键词: 12 year old; Address; Age; Attention deficit hyperactivity disorder; Behavior; Behavioral; Biological Markers; Brain; Caring; Characteristics; Child; Clinical; Cognitive; Communities; Consumption; Data; Development; Devices; Double-Blind Method; Effectiveness; Electroencephalography; Ensure; Exhibits; Family; Frequencies; Functional disorder; High Prevalence; Home; Individual; Intervention; Literature; Measurement; Mediating; Mediator; Methods; Minority; National Institute of Mental Health; Outcome; Parents; Patients; Pharmaceutical Preparations; Pilot Projects; Prediction of Response to Therapy; Psychiatry; Quality of life; Randomized; 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; behavior prediction; 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; randomized, clinical trials; 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.

项目概要/摘要 注意力缺陷/多动障碍 (ADHD) 的患病率很高（4-17 岁儿童的 5-11%）， 加上其高昂的社会成本、强烈的持久性以及对生活质量的有害影响，有理由继续 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 一个重大挑战，可能与多种因果路径有关，并导致临床表现的变异性， 潜在的神经机制和治疗反应。尽管精神兴奋剂是黄金标准 ADHD 的治疗、反应欠佳、不良副作用和不依从性等问题 患有多动症的人中占很大一部分。因此，迫切需要经验支持的非 ADHD 的药物干预。此外，还有一种预测治疗反应的可靠方法 ADHD（以及一般精神病学）的干预措施，包括药物和非药物方法， 仍然难以捉摸。无法前瞻性地预测治疗方法对于给定的情况是否有效 对于专业人士和患者来说，个人的诊断是昂贵且耗时的，并且由于以下原因常常没有结论： 举报人之间存在分歧。在这个项目中，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) 的功效，这是一种新型、风险最小、非侵入性的方法 神经调节治疗，针对 7-12 岁儿童 ADHD（N=180）。这个影响深远的项目将 对多动症的经验支持的非药物干预文献做出了重大贡献， 识别潜在的神经机制，并测试临床有用的治疗行为和认知预测因子 回复。确认 TNS 对 ADHD 的功效可以为数百万家庭提供可行的非治疗方法 药物治疗选择，在某些情况下，作为多动症患者的一线治疗策略，如果 得到这项研究的支持。验证可显着预测治疗的行为特征 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 并加强向社区传播治疗。该提案与 NIMH 的多项提案一致 优先事项，包括制定创新干预措施、评估行动机制 对大脑进行有效的干预并识别行为和认知特征以指导 治疗方法。