Saturday, September 7, 2024
9/7/2024
Despite a wide-ranging interest in performing clinical research for bioelectronic medicine applications, there are no open-architecture and open-source implantable systems for autonomic nerve stimulation and recording available to researchers. As a result, progress towards bioelectronic clinical therapies is hampered by the significant technical, regulatory, and financial hurdles faced by researchers to gain access to the few commercial implantable neuromodulation technologies for early clinical studies. The few clinical closed-loop implantable neuromodulation systems presently available are not suitable for the many bioelectronic medicine applications envisioned, as they lack key functional modules for accessing the autonomic nerves; moreover, most use closed architectures (e.g., the use of custom ASICs instead of commercial over-the-shelf components) and proprietary software, limiting the ability to adapt such systems for different clinical indications. To address these shortcomings, the overall objective of this HORNET Center for Autonomic Nerve Recording and Stimulation Systems (CARSS) is to develop and disseminate a fully open-architecture and open-source implantable system for autonomic nerve stimulation and end-organ sensing. In this administrative supplement, we will perform short-term and long-term validation of the CARSS system functionality in small and large animals for three intended use cases: bladder control, hypoglycemia, and unidirectional nerve block. The CARSS system includes an external charger and controller, implantable pulse generator, and an assortment of implantable leads for nerve stimulation and end-organ sensing. The use of sacral anterior root stimulation for treating neurogenic bladder dysfunction and the use of vagus nerve stimulation for treating hypoglycemia were selected based on potential clinical indications that are of interest to the NIH SPARC program. Validation of the synchronized low- frequency alternating current block was selected, as unidirectional activation of the vagus nerve can be applied for several bioelectronic medicine indications, such as hyperglycemia, chronic inflammatory diseases, and heart failure.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
