Advanced Open Source In Silico Solution for Device Development, Treatment Planning, and Virtual Clinical Trials in Bioelectronic Medicine

The success of bioelectronic medicine for the treatment and diagnosis of disease and injury relies on the possibility to safely and effectively modulate neural function to impact organ physiology in order to treat a variety of diseases or to restore lost body functionalities. The aim of the Open Online Simulations for Stimulating Peripheral Activity to Relieve Conditions (o2S2PARC) platform – currently being developed by the IT’IS Foundation and funded by the NIH SPARC Initiative – is to advance the future of in silico modeling for bioelectronic medicine by providing the tools for the simulation of the peripheral nerve system neuromodulation/stimulation and its interaction with the organ physiology in a precise and predictive manner. The platform exploits web-based technologies and open-source concepts to benefit from the most recent computational/web advancement and supports free sharing and integration of advanced neuronal models from the scientific and in particular the SPARC community. o2S2PARC will facilitate mechanistic investigations of the impact of physical exposure (e.g., to electromagnetic (EM) fields, ultrasound) and of neuronal networks (e.g., coupled EM-neurostimulations). It will also help to optimize and design new generations of medical devices and improve selectivity and treatment outcome, assess and minimize side effects and risks, and facilitate personalized treatment. It will therefore play a central role in the research fields of computational modeling of neuromodulation and in the development of electroceuticals and neuroprosthetics in particular. Furthermore, o2S2PARC includes a dedicated regulatory effort with a focus on requirements for model verification, validation, and certification in order to achieve a regulatory-grade implementation. Interoperability with other initiatives, e.g., the BlueBrain project, is envisaged.