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

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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 modules for accessing the autonomic nerves; moreover, many of them use closed architectures. To address this challenge, we propose to develop the implantable leads for the implantable pulse generator (IPG) platform, which will be based on a flexible, open-architecture, and modular approach. A large selection of stimulation and sensing leads will be developed for interfacing with the IPG header. Specifically, we will develop a polydimethylsiloxane-based cuff for stimulation of autonomic nerves with the diameter of 1 mm and larger. We will also develop a lead for sacral nerve stimulation. For enabling closed-loop neuromodulation, we will develop the leads for electrocardiographic, electromyographic, electroneurographic, and accelerometer-based motility sensing. Such flexibility and modularity will allow a significant degree of customization for different clinical indications, including open-loop and closed-loop IPG operation. Once the implantable leads are developed, they will be subjected to the benchtop testing.