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

HORNET 自主神经记录和刺激系统中心 (CARSS)

• 批准号: 10706610
• 负责人: Raja Edward Hitti
• 金额: $ 384.01万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 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/10706610
• 关键词: Academia; Acceleration; Accelerometer; Administrator; Advisory Committees; Ally; Anser species; Architecture; California; Cellular Phone; Clinical; Clinical Research; Collaborations; Communities; Computer software; Custom; Dedications; Development; Diameter; Documentation; Education; Education and Outreach; Electrocardiogram; Electromyography; Electronics; Ensure; Face; Feedback; Geese; Goals; Home; Human; Implant; Industry; Institution; Lead; Leadership; Libraries; Los Angeles; Mechanics; Medical; Medicine; Mind; Modality; Motion; Nerve; Patients; Physiologic pulse; Postdoctoral Fellow; Principal Investigator; Productivity; Raja; Reporting; Research; Research Personnel; Sacral nerve; Scheme; Source; Structure; System; Tablets; Technology; Time; Training; Translations; Universities; Work; autonomic nerve; bioelectronics; career; community engagement; design; flexibility; interest; interoperability; member; neuroregulation; neurotechnology; novel; open source; operation; polydimethylsiloxane; programs; sensor; software systems; technology platform

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.

尽管人们对生物电子医学应用的临床研究有着广泛的兴趣，但 没有可用的开放架构和开源植入系统用于自主神经刺激和 记录。因此，临床研究人员在获得药物方面面临着重大的技术、监管和财务障碍。 获得进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植入式神经调节系统可用，它们具有 有助于支持临床研究。然而，就目前的形式而言，没有一个适合生物电子学 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 其中使用封闭架构（例如，使用定制 ASIC 而不是商业现货 组件）和专有软件。 因此，该 HORNET 自主神经记录和刺激中心的总体目标 Systems (CARSS) 致力于开发一种开放架构和开源的自主神经植入系统 刺激和记录。我们建议开发专为生物电子学设计的CARSS植入系统 医学应用。 CARSS 系统包括外部充电器和控制器、植入式脉冲 发生器，以及各种用于刺激和传感的可互操作和植入式导线。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 临床研究界的灵活性和控制力。 为了向社区提供开发的系统及其组件，我们的 CARSS 中心 将通过提供系统模板和用户社区参与并促进技术传播 图书馆（以及支持技术文档）以及培训。我们的中心目标 传播方法是与社区合作，减少技术、监管和财务方面的影响 进入生物电子医学研究的壁垒，从而加速生物电子医学研究的开发和转化 新颖的生物电子医学疗法。我们组建了一支来自工业界和学术界的协作团队 实现适合人类临床研究的 CARSS 系统。