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 and proprietary software. To address this challenge, we propose to develop the PCBA and firmware for the implantable pulse generator (IPG) platform and external charger, which will be based on a flexible, open-architecture, open-source, and modular approach. Such flexibility will allow a significant degree of customization for different clinical indications, including open-loop and closed-loop IPG operation. The PCBA and firmware modules will be designed for interfacing with a large selection of sensing and stimulation leads. Once the IPG and charger modules are developed, they will be subjected to the benchtop testing.

Not applicable per solicitation. Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRAsystems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.