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学，并且迷走神经控制中的障碍已经牵涉到若干病理生理学状况。然而，尽管全世界有超过100，000个VNS植入物用于治疗癫痫、抑郁、焦虑和胃肠道疾病，但缺乏关于人类这种神经的生理学以及迷走神经刺激（VNS）的多器官反应的信息。同样，关于如何最好地优化现有疗法的VNS设置或如何为新疗法开发VNS，也知之甚少。拟议的研究评估迷走神经兴奋和解剖联系（REVEAL）中心旨在对VNS对四个关键系统的影响进行开创性研究：自主神经系统（ANS），心血管系统，免疫系统和代谢系统。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，其中包括40多名参与的关键人员，140多名患者，一个外部咨询委员会（包括患者倡导者），一个数据和安全监测委员会，一个NIH指导委员会和其他NIH人员。REVEAL将有三个目标与其核心相对应。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，以获得关于VNS对ANS、心血管系统、免疫系统和代谢影响的一致数据。数据和分析核心将收集、存储和分析来自临床站点的数据，以生成公开可用的数据集，用于开发基于VNS的疗法和其他研究。管理核心将协调REVEAL核心和利益相关者的工作，以实现NIH的VESPA计划的目标。