Problem
Bioelectronic medicine is a rapidly growing field which uses neuromodulation of peripheral nerves to treat conditions involving disorders in cardiovascular control, gastrointestinal motility, immune response, and other autonomic processes. While several therapies based on bioelectronic medicine concepts have recently entered clinical trials, there are still major barriers to getting a new therapy from animal experiments into human treatment. In part, this is driven by the high cost and resources necessary to build human-grade devices and the inability of existing devices to meet the needs of new therapies. There is a need for neuromodulation devices that can accelerate the advancement of bioelectronic medicine and can be used at every stage of therapy development–from large animal exploratory studies to animal studies that advance specific therapies, to human clinical studies.
Solution
The Center for Autonomic Recording and Stimulation Systems (CARSS) is working to create just such a solution. CARSS is a partnership between the University of Southern California and two medical device companies, Med-Ally LLC and Medipace Inc., to develop open-source devices for neuromodulation. CARSS is composed of researchers, medical device engineers, and contract manufacturers with experience in animal studies and clinical trials.
With support from SPARC, CARSS is developing OpenNerve.
Figure 1. OpenNerve logo
A flexible and powerful device for bioelectronic medicine. OpenNerve is designed to enable testing of new therapies in both animal (and soon) human research. Importantly, all design files, source code, and protocols for fabrication and testing are released on CARSS’s GitHub page under the CC-BY 4.0 open source license, allowing researchers full access to the platform to modify it or build on top of it for the disease they are targeting. For Investigational Device Exemption (IDE)-enabling studies and human trials, OpenNerve components developed by CARSS industry partners will be manufactured under manufacturing controls to allow submission to the FDA for human use.
OpenNerve is based on existing implantable pulse generators (IPGs) and connections to the target tissue (leads) for neural recording and stimulation, with additional novel sensors to help drive the development of new personalized and adaptive therapies. The OpenNerve IPG contains electronics for stimulation and impedance measurement as well as analog front ends for biosignals such as neural signals, heart rate, and muscle activation.
Figure 2. OpenNerve contains an implantable pulse generator (IPG) with both stimulation and sensing leads for personal, adaptive bioelectronic medicine therapies. Bluetooth communication allows for data visualization and control using an external device, or via networking to other sensors
Figure 3. The OpenNerve IPG connected to two linear electrode arrays for sacral or spinal cord stimulation, two nerve cuffs of differing diameters, and a strain sensor. Using a splitter, each IPG can be used with up to 8 leads.
We are currently offering leads based on existing clinical devices, including leads to interface with the vagus nerve innervating the internal organs, the sacral nerves at the base of the spine, tiny branch nerves in the abdomen, and leads for acquiring biosignals. In addition, a number of research leads are under development including mechanical sensors for strain and temperature and chemical sensors for acetylcholine, catecholamines, and pH levels.
Impact
The OpenNerve device will accelerate therapies from the research lab to the clinic, where they can help patients with chronic diseases. Furthermore, by releasing design documents and testing data publicly under open source licenses, we hope to improve the translation of novel therapies from the lab to the clinic, both academically and commercially. Our belief is that by lowering the barrier for new therapy development, we can accelerate the path to the clinic for new treatments and enable commercialization of therapies for orphaned or rare diseases that do not have the patient population to support new device development costs.
CARSS is actively looking for collaborators who are interested in bringing new bioelectronic medicine therapies to the clinic. We can support studies ranging from feasibility work in large animals through IDE-enabling GLP studies and initial clinical tests; if you’d like to learn if our resources can support your translational work please reach out to CARSS@usc.edu.
