REVEAL - Research Evaluating Vagal Excitation and Anatomical Linkages.

REVEAL - 评估迷走神经兴奋和解剖联系的研究。

• 批准号: 10610556
• 负责人: Lynn E Eberly
• 金额: $ 699.7万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10610556
• 关键词: Academia; Advocate; Anatomy; Anxiety Disorders; Autonomic nervous system; Big Data; Budgets; Cardiovascular system; Clinical; Clinical Data; Clinical Research; Clinical Trials Data Monitoring Committees; Communication; Data; Data Analyses; Data Set; Development; Devices; Electric Stimulation; Ensure; Epilepsy; Foundations; Future; Gastrointestinal Diseases; Goals; Human; Human Resources; Immune; Immune system; Implant; Industry; Institution; Medical; Mental Depression; Metabolic; Metabolism; Multi-Institutional Clinical Trial; Nerve; Nervous System Physiology; Outcome; Patients; Physiological; Physiology; Productivity; Protocols documentation; Research; Research Design; Research Personnel; System; Therapeutic; United States National Institutes of Health; Vagus nerve structure; Work; base; biophysical model; clinical research site; data ecosystem; experience; meetings; model development; multidisciplinary; neuroregulation; novel therapeutics; predictive modeling; programs; response; technology development; therapeutic development

OVERALL Abstract The vagus nerve is involved in normal physiology, and disturbances in vagal control have been implicated in several pathophysiological conditions. However, there is a lack of information on the physiology of this nerve in humans as well as multi-organ responses to vagal nerve stimulation (VNS), despite over 100,000 VNS implants worldwide to treat epilepsy, depression, anxiety, and gastrointestinal disorders. Likewise, very little is known about how to best optimize VNS settings for existing therapies or how to develop VNS for new therapies. The proposed Research Evaluating Vagal Excitation and Anatomical Linkages (REVEAL) center aims to conduct groundbreaking research on the effect of VNS on four key systems: the autonomic nervous system (ANS), the cardiovascular system, the immune system, and metabolic system. The ambitious scope of the research requires the participation of eight major academic and medical institutions with over 40 participating key personnel, over 140 patients, an External Advisory Board (which includes patient advocates), a Data and Safety Monitoring Board, and an NIH Steering Committee and other NIH personnel. REVEAL will have three aims corresponding to its Cores. The Clinical Core will manage over 140 patients and clinical staff from 8 different institutions to obtain consistent data on VNS effects on ANS, the cardiovascular system, the immune system, and metabolism. The Data and Analysis Core will gather, store, and analyze data from clinical sites to produce publicly available datasets for development of VNS-based therapeutics and other research. The Administration Core will coordinate the work of the REVEAL Cores and stakeholders to meet the goals of NIH SPARC’s VESPA program.

总体摘要 迷走神经参与正常生理，迷走神经控制紊乱与多种病理生理状况有关，但是，缺乏有关人类迷走神经生理学以及对迷走神经刺激的多器官反应的信息。 VNS），尽管全世界有超过 100,000 个 VNS 植入物用于治疗癫痫、抑郁症、焦虑症和胃肠道疾病。同样，人们对如何最好地优化 VNS 设置知之甚少。拟议的迷走神经兴奋和解剖联系研究评估 (REVEAL) 中心旨在对 VNS 对四个关键系统的影响进行突破性研究：自主神经系统 (ANS)、心血管系统。这项雄心勃勃的研究范围需要八个主要学术和医疗机构的参与，包括 40 多名参与关键人员、140 多名患者、一个外部顾问委员会（包括患者倡导者）、一个数据中心。临床核心将管理来自 8 个不同机构的 140 多名患者和临床工作人员，以获得有关 VNS 对 ANS 影响的一致数据。数据和分析核心将收集、存储和分析来自临床站点的数据，以生成公开的数据集，用于开发基于 VNS 的疗法和其他研究。这REVEAL 核心和利益相关者，以实现 NIH SPARC 的 VESPA 计划的目标。