Data and Analysis Core

数据和分析核心摘要 现在有一个重要的机会来利用尖端的统计和建模技术来完善我们对迷走神经在颈部水平的招募如何影响代谢组学、细胞因子和炎症标志物、心血管功能和其他由自主神经系统(ANS)支配的系统的理解。我们数据和分析核心(DAC)的总体目标是(1)开发一个多中心“大数据生态系统”，以收集我们临床站点合作伙伴中的人类VNS数据；(2)创建模型、模拟和可视化工具，使用户能够探索和分析VNS的特定参数如何影响人类的代谢、细胞因子和炎症以及心血管功能，以及(3)通过SPARC门户网站传播数据和结果。我们建议利用一个多层次的数据收集、分析和建模研究框架，该框架将提供一套新颖的回顾分析和前瞻性优化模型，以支持拟议的共同研究议定书(CSP)和3个附属项目。 明尼苏达大学(UMN)将与梅奥诊所、圣路易斯华盛顿大学、南卡罗来纳医科大学(MUSC)、谢泼德-普拉特医院、斯坦福大学和澳大利亚贝克研究所/莫纳什大学合作。数据将通过对144名VNS患者的临床评估收集，包括以前植入的(p-VNS；N=48)和新植入的(n-VNS，N=96)组。N-VNS患者将被植入LivaNova的标准临床设备或IDE监管的名为MicroBurst的新型LivaNova设备，该设备能够实现比临床可用的更广泛的刺激参数范围。我们将按照临床核心研究战略的描述，研究急性和慢性VNS对外周系统生理学的影响。 UMN生物识别研究协调中心和BLART是一家经验丰富的合同研究组织，在设备研究方面具有特殊专长，将负责包括监管和数据审计在内的总体协调。此外，通过现有的SPARC奖项在数据可视化方面拥有丰富经验的BIOS Health将负责协助开发可视化和数据工作流程工具，并将其集成到SPARC DRC门户网站中。发改委领导将每月与所有现场绩效指标、调查人员和相关工作人员举行会议，以确保及时执行揭示项目的数据收集、协调、分析、模拟、可视化和传播。这些数据将提供人类迷走神经功能连接的多系统视图，填补一个关键的知识空白，并为现有的和新的基于迷走神经的治疗方法的开发提供基础。

DATA AND ANALYSIS CORE Abstract There is a significant opportunity to leverage cutting-edge statistical and modeling techniques to refine our understanding of how vagus nerve recruitment at the cervical level affects metabolomics, cytokine and inflammation markers, cardiovascular function, and other systems innervated by the autonomic nervous system (ANS). Our overarching goal for the Data and Analysis Core (DAC) is to (1) develop a multi-center “big data ecosystem” to collect human VNS data across our clinical site partners; (2) create models, simulations, and visualization tools that enable users to explore and analyze how specific parameters of VNS affect metabolic, cytokine and inflammatory, and cardiovascular function in humans, and (3) disseminate the data and results through the SPARC Portal. We propose to utilize a multi-tiered data collection, analysis, and modeling research framework that will provide a novel set of retrospective analyses and prospective optimization models to support the proposed Common Study Protocol (CSP) and 3 Ancillary Projects. The University of Minnesota (UMN) will partner with the Mayo Clinic, Washington University in St. Louis, Medical University of South Carolina (MUSC), Sheppard-Pratt Hospital, Stanford University, and the Baker Institute/Monash University (Australia). Data will be collected across a battery of assessments on 144 VNS patients across clinical sites, consisting of previously implanted (p-VNS; N=48) and newly implanted (n-VNS, N=96) groups. The n-VNS patients will be implanted with a standard clinical device by LivaNova or an IDE- regulated novel LivaNova device called Microburst, which enables a wider range of stimulation parameters than what is clinically available. We will investigate the effects of acute and chronic VNS on the physiology of the peripheral systems as described in the Clinical Core research strategy. The Coordinating Centers for Biometric Research at UMN and BRIGHT, an experienced contract research organization with a special expertise in device studies, will handle the overarching coordination including regulatory and data auditing. Additionally, BIOS Health, which has significant experience with data visualization through an existing SPARC award, will be responsible for assisting with the development and integration of visualization and data workflow tools into the SPARC DRC Portal. DAC Leads will hold monthly meetings with all site PIs, investigators, and relevant staff to ensure timely execution of data collection, coordination, analysis, simulations, visualizations, and dissemination for the REVEAL Project. These data will provide a multi-system view of the vagus nerve’s functional connectivity in humans, filling a critical knowledge gap and providing a foundation for the development of existing and new VNS-based therapies.