Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction
(Jianfeng Zheng, UH CEMC; Eugene Civillico, FDA)
Background: Stimulation of nervous tissue by electrical, magnetic, or acoustic energy is the functional mechanism of several leading-edge device therapies. Yet, the relation between stimulus parameters and cellular effects is incompletely mapped, restricting the possible therapeutic options for many devices. For example, in the area of electrical stimulation, the Shannon equation is used to describe the boundary between damaging and non-damaging levels of electrical stimulation. While it is a helpful guide for macroelectrode stimulation, it is modeled on a limited set of stimulation parameters and time points. For novel stimulation devices and paradigms, the FDA, industry, and academia rely on behavioral changes and histology to assess neural effects. These methods are inefficient to address the full spectrum of stimulation devices and paradigms. Methods capable of quickly and effectively monitoring and evaluating stimulation effects are needed to facilitate rapid patient access to safe and effective novel neurostimulation devices.
Research Plan: Assess the cellular effects of neurostimulation technologies on cells, tissues, and organisms using multi-electrode arrays. Measurements from our studies are used to parameterize computational models that can predict the effects of stimulation. Our major current focus is identifying safe and effective parameter ranges for intracortical microstimulation (ICMS) to enable future brain-computer interface (BCI) devices. The REU student will be involved in all aspects of the research, including experimental preparation, data collection and analysis, and preparation of reports (e.g., conference presentations and publications).
Prerequisites: An introductory course in neuroscience and knowledge of at least one scientific programming language are desirable.
Dr. Eugene Civillico, Ph.D., leads the Neurotechnology Regulatory Science Tools Program in the Division of Biomedical Physics at FDA/CDRH/OSEL. He received his A.B. in Biology from Harvard University, Cambridge, MA and his Ph.D. in neuroscience from the University of Pennsylvania School of Medicine, Philadelphia, PA. Following postdoctoral training in cerebellar physiology and two-photon microscopy, Dr. Civillico joined Otsuka Pharmaceutical Company, where he led a small early-stage discovery team. From 2016–2021 he developed and managed bioengineering research programs at NIH, including Stimulating Peripheral Activity to Approve Conditions (SPARC), Rapid Acceleration of Diagnostics (RADx), and Bridge2AI. He served as Executive Director of Northeastern University’s Multiscale Imaging of Living Systems before returning to CDRH in 2023. He is a frequent contributor to DARPA and ARPA-H programs.
Dr. Civillico’s research in CDRH addresses gaps in the advancement of safe and effective neurotechnologies to patients. Focus areas include 1) safe and effective engagement of devices with neural tissue, and 2) validation of quantitative diagnostic biomarkers for neurological and physical medicine indications. His peer-reviewed work extends from single cells to humans.
https://www.linkedin.com/in/genecivillico/