Data and Analysis Core

数据与分析核心

• 批准号: 10610559
• 负责人: Matthew Douglas Johnson
• 金额: $ 91.91万
• 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/10610559
• 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; Clinical Research; Collaborations; Communities; Data; Data Analyses; Data Collection; Data Set; Development; Devices; Ensure; Epilepsy; Fiber; Foundations; Generations; Goals; Health; Heart Rate; Hospitals; Human; Immune; Immune system; Implant; Inflammatory; Institutes; 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; Secure; Site; South Carolina; Specific qualifier value; Statistical Data Interpretation; Statistical Models; Supercomputing; System; TNF gene; Techniques; Testing; Time; Universities; Vagus nerve structure; Visualization; Visualization software; Washington; Work; base; biophysical model; clinical research site; cytokine; data ecosystem; data modeling; data resource; data visualization; design; experience; experimental study; industry partner; inflammatory marker; meetings; metabolomics; model development; models and simulation; 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 有一个很好的机会利用尖端的统计和建模技术来加深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”，以在我们的临床站点合作伙伴中收集人类 VNS 数据；(2) 创建模型、模拟和可视化工具；使用户能够探索并分析 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 门户传播数据和结果。我们建议利用多层数据收集、分析和建模研究。该框架将提供一套新颖的回顾性分析和前瞻性优化模型，以支持拟议的共同研究协议（CSP）和 3 个辅助项目。 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、斯坦福大学和贝克研究所/莫纳什大学数据中心合作。将收集对临床中心 144 名 VNS 患者进行的一系列评估，其中包括先前植入的组（p-VNS；N=48）和新植入的组（n-VNS，N=96）。 n-VNS 患者将被植入 LivaNova 的标准临床设备或名为 Microburst 的 IDE 调节的新型 LivaNova 设备，该设备能够提供比临床可用的更广泛的刺激参数。我们将研究急性和慢性 VNS 的影响。临床核心研究策略中描述的外围系统的生理学。 UMN 的生物识别研究协调中心和 BRIGHT（一家在设备研究方面拥有特殊专业知识的经验丰富的合同研究组织）将处理包括监管和数据审计在内的总体协调。此外，BIOS Health 在通过现有的数据可视化方面拥有丰富的经验。 SPARC 奖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 门户中。 DAC 负责人将每月与所有站点 PI、调查人员和相关人员举行会议，以确保及时完成。 REVEAL 项目的数据收集、协调、分析、模拟、可视化和传播的执行这些数据将为人类迷走神经功能连接提供多系统视图，填补关键的知识空白并为开发提供基础。现有的和新的基于 VNS 的疗法。