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: 10557000
• 负责人: Raja Edward Hitti
• 金额: $ 402.03万
• 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/10557000
• 关键词: Academia; Accelerometer; Administrator; Advisory Committees; Ally; Anser species; Architecture; Caliber; California; Cellular Phone; Charge; Clinical; Clinical Research; Collaborations; Communities; Computer software; Custom; Development; Documentation; Education; Ensure; Face; Feedback; Goals; Head; Home; Human; Industry; Institution; Lead; Leadership; Libraries; Los Angeles; Mechanics; Medical; Medicine; Mind; Modality; Motion; Nerve; Patients; Physiologic pulse; Postdoctoral Fellow; Principal Investigator; Raja; Reporting; Research; Research Personnel; Sacral nerve; Scheme; Source; Structure; System; Tablets; Technology; Time; Training; Translations; Universities; Work; autonomic nerve; base; bioelectronics; career; community engagement; design; flexibility; interest; interoperability; member; neuroregulation; neurotechnology; novel; open source; operation; outreach; polydimethylsiloxane; programs; sensor; software systems

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.

尽管对对生物电子医学应用进行临床研究的兴趣广泛，但仍有 没有可用的开放式结构和开源植入系统用于自主神经刺激和 记录。结果，临床研究人员面临着重大的技术，法规和财务障碍 访问进行这些临床研究所需的可植入神经调节技术。 目前有几种可用的临床闭环神经调节系统 有助于支持临床研究。但是，以目前的形式，不适合生物电子 医学应用，因为它们缺乏访问自主神经的关键功能模块；而且，许多 他们中的使用封闭的体系结构（例如，使用定制的ASIC而不是商业上的架子 组件）和专有软件。 因此，这个大黄蜂的自主神经记录和刺激中心的总体目标 系统（CARSS）是为自主神经开发开放式和开源植入系统 刺激和记录。我们建议开发针对生物电子量身定制的汽车植入系统 医学应用。汽车系统包括外部充电器和控制器，可植入的脉冲 发电机，以及可互操作和可植入的导线进行刺激和传感。因此，这个 无缝统一的系统将实现闭环传感和神经调节，提供实验 灵活性和控制临床研究社区。 为了使开发系统及其组件可用于社区，我们的汽车中心 将与用户社区互动，并通过提供系统模板和 图书馆（以及支持技术文档）以及培训。我们的核心目标 传播方法是与社区合作，以减少技术，法规和财务 进入生物电子医学研究的障碍，从而加速了 新型生物电子医疗疗法。我们已经组建了一个从行业和学术界的合作团队 实现适用于人类临床研究的汽车系统。