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.

The 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 to support clinical research for bioelectronic medicine applications. This CARSS system will consist of an (1) external charger and controller, (2) implantable pulse generator, and (3) an interoperable assortment of implantable leads for stimulation and sensing. A central goal of the effort is to enable access to the developed technology in a manner that will dramatically 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.