An Open-Source Platform for Clinical Autonomic Neuromodulation Therapies

<br/>The field of bioelectronic medicine is rapidly progressing, with emerging therapeutic approaches necessitating precise closed-loop control of neural activity in peripheral nerves like the vagus nerve, sacral nerve, pudendal nerve, enteric nervous system, and others. However, transitioning neuromodulation therapies for human clinical application poses significant challenges due to the high costs and lengthy development timelines required for implantable devices suitable for human use. Presently, many clinical research teams rely on off-the-shelf commercial devices for testing on both large animals and humans. These commercial devices are often tailored to specific applications and may not align with the requirements of novel therapies. Collaborations with large corporations can be complicated by potential conflicts of interest that hinder successful partnerships. Furthermore, existing devices often lack the capacity to record biomarkers from multiple sites, limiting their therapeutic potential. As a result, access to customizable neuromodulation technology stands as a substantial obstacle to scientific breakthroughs and the advancement of new treatments.<br/><br/>The CARSS Center, a collaborative venture involving the University of Southern California, Medipace Inc., and Med-Ally LLC, aims to address this challenge. They are creating an open-source system for closed-loop autonomic neuromodulation specifically designed for human clinical investigations. The CARSS system consists of an implantable pulse generator (IPG) equipped with Bluetooth capabilities and native support for running machine learning algorithms. Additionally, it includes a variety of leads for both stimulation and sensing purposes. The initial set of leads comprises a vagus nerve cuff and a sacral nerve linear array with combined stimulation and neural sensing capabilities, as well as electrocardiography, electromyography, and motion sensing leads for physiological monitoring. Further leads in development encompass sensing leads for neurotransmitters such as acetylcholine and catecholamines, as well as physical sensing leads for strain and end-organ temperature. CARSS is actively seeking collaborators interested in utilizing the system to conduct comprehensive studies on large animals, with the goal of eventually advancing these therapies to initial use in human patients.