Data and Analysis Core

数据与分析核心

• 批准号: 10709639
• 负责人: Matthew Douglas Johnson
• 金额: $ 116.6万
• 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/10709639
• 关键词: Acute; Affect; Anatomy; Australia; Autonomic nervous system; Award; Big Data; Biometry; Biophysics; Blood Pressure; Cardiovascular Physiology; Cardiovascular system; Cervical; Chronic; Clinic; Clinical; Collaborations; Communities; Data; Data Collection; Data Set; Development; Devices; Ensure; Epilepsy; Experimental Designs; Fiber; Foundations; Generations; Goals; Health; Heart Rate; Hospitals; Human; Immune; Immune system; Implant; Inflammatory; Knowledge; Late Effects; Location; Medical; Mental Depression; Metabolic; Minnesota; Modeling; Monitor; Muscle; Nerve; Neurosciences; Outcome Measure; Participant; Patients; Peripheral; Physiology; Process; Protocols documentation; Research; Research Contracts; Research Design; Research Personnel; Resources; Secure; Site; South Carolina; Specific qualifier value; Statistical Data Interpretation; Supercomputing; System; TNF gene; Techniques; Testing; Time; Universities; Vagus nerve structure; Visualization; Visualization software; Washington; Work; biophysical model; clinical research site; cytokine; data ecosystem; data modeling; data visualization; design; experience; industry partner; inflammatory marker; meetings; metabolomics; neural model; novel; predictive modeling; prospective; recruit; research and development; response; simulation; therapeutic development; tool

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.

数据与分析核心摘要 利用尖端的统计和建模技术来完善我们对颈部迷走神经募集如何影响代谢组学，细胞因子和炎症标志物，心血管功能以及自主神经系统（ANS）支配的其他系统的理解是一个重要的机会。我们的数据和分析核心（DAC）的总体目标是（1）开发一个多中心的“大数据生态系统”，以收集我们临床研究中心合作伙伴的人类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，及（3）透过电子数据库网站发放有关数据及结果。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，将提供一套新的回顾性分析和前瞻性优化模型，以支持拟议的通用研究协议（CSP）和3个辅助项目。 明尼苏达大学（UMN）将与马约诊所、圣路易斯华盛顿大学、南卡罗来纳州医科大学（MUSC）、谢泼德-普拉特医院、斯坦福大学和贝克研究所/莫纳什大学（澳大利亚）合作。将在临床试验机构的144例VNS患者的一系列评估中收集数据，包括既往植入组（p-VNS; N=48）和新植入组（n-VNS，N=96）。n-VNS患者将植入LivaNova的标准临床器械或IDE监管的新型LivaNova器械（称为Microburst），该器械可实现比临床可用参数更广泛的刺激参数。我们将研究急性和慢性迷走神经刺激对外周系统生理学的影响，如临床核心研究策略所述。 UMN和BRIGHT的生物识别研究协调中心是一家经验丰富的合同研究组织，在器械研究方面具有特殊专长，将负责总体协调，包括监管和数据审核。此外，BIOS Health通过现有的数据可视化奖在数据可视化方面拥有丰富的经验，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IDC门户网站中。DAC负责人将每月与所有研究中心PI、研究者和相关工作人员举行会议，以确保及时执行REVEAL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，填补关键的知识空白，并为现有和新的基于VNS的疗法的开发提供基础。