Data and Analysis Core

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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.