HORNET Center for Autonomic Nerve Recording and Stimulation Systems (CARSS)

尽管对生物电子医学应用进行临床研究有广泛的兴趣， 没有用于自主神经刺激的开放架构和开源植入式系统， 录制.因此，临床研究人员在获得技术、监管和财务方面面临重大障碍。 获得执行这些临床研究所需的植入式神经调节技术。 目前有几种临床闭环可植入神经调节系统，它们具有 有助于临床研究。然而，在他们目前的形式，没有一个是适合的生物电子 医学应用，因为它们缺乏访问自主神经的关键功能模块;此外，许多 它们中的一些使用封闭的体系结构（例如，使用定制ASIC，而不是商用现货 组件）和专有软件。 因此，HORNET自主神经记录和刺激中心的总体目标 系统（CARSS）的目标是开发一种开放式结构和开源的自主神经植入式系统 刺激和记录。我们建议开发CARSS植入式系统， 医药应用。CARSS系统包括外部充电器和控制器、植入式脉冲 发生器，以及各种可互操作和植入式电极导线，用于刺激和感知。因此，这 无缝统一的系统将实现闭环传感和神经调节，提供实验性的 灵活性和控制力。 为了使开发的系统及其组件可供社区使用，我们的CARSS中心 将通过提供系统模板，与用户社区接触，促进技术传播， 图书馆（沿着支持技术文档）以及培训。我们的中心目标是 传播方法是与社区合作，以减少技术，监管和财务 进入生物电子医学研究的障碍，从而加速开发和翻译 新的生物电子医学疗法。我们组建了一个来自工业界和学术界的合作团队， 实现适用于人类临床研究的CARSS系统。

Despite a wide-ranging interest in performing clinical research for bioelectronic medicine applications, there are no available open-architecture and open-source implantable systems for autonomic nerve stimulation and recording. As a result, clinical researchers face significant technical, regulatory, and financial hurdles in getting access to the implantable neuromodulation technologies that are required for performing these clinical studies. There are several clinical closed-loop implantable neuromodulation systems presently available and they have been helpful in supporting clinical research. However, in their current form, none are suitable for the bioelectronic medicine applications, as they lack key functional modules for accessing the autonomic nerves; moreover, many of them use closed architectures (e.g., the use of custom ASICs instead of commercial over-the-shelf components) and proprietary software. Therefore, the overall objective of this HORNET Center for Autonomic Nerve Recording and Stimulation Systems (CARSS) is to develop an open-architecture and open-source implantable system for autonomic nerve stimulation and recording. We propose to develop the CARSS implantable system tailored for bioelectronic medicine applications. The CARSS system includes an external charger and controller, implantable pulse generator, and an assortment of interoperable and implantable leads for stimulation and sensing. As such, this seamlessly unified system will enable closed-loop sensing and neuromodulation, providing experimental flexibility and control to the clinical research community. In order to make the developed system and its components available to the community, our CARSS Center will engage with the user community and facilitate technology dissemination by providing system templates and libraries (along with supporting technical documentation) as well as training. The central goal of our dissemination approach is to collaborate with the community to reduce the technical, regulatory, and financial barriers to entry into bioelectronic medicine research and thereby accelerate the development and translation of novel bioelectronic medical therapies. We have assembled a collaborative team from industry and academia to achieve a CARSS system suitable for use in human clinical research.