Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction
Background: Neuromodulation devices implanted in the brain are increasingly used for the treatment of neurological diseases and the restoration of sensory and motor function. Yet, concerns over neural tissue and functional damage produced by electrical stimulation constrain the available stimulation parameter range, which restrict the possible therapeutic options for many devices. Currently, 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 damage. These methods are inefficient to address the acute and long-term safety concerns of the full spectrum of stimulation devices and paradigms. Methods capable of quickly and effectively monitoring and evaluating stimulation safety are needed to facilitate rapid patient access to safe and effective novel neurostimulation devices.
Research Plan: The primary goal of this proposal is to develop a multi-scale non-clinical evaluation platform for efficient and real-time assessment of electrical stimulation safety. This study will determine the acute and chronic activation and safety threshold of intracortical microstimulation (ICMS), investigate the use of electrophysiological signals for the real-time detection of neural damage, and develop computational model of electrical field distribution for the prediction of the safety of ICMS.
Prerequisites: An introductory course in neuroscience and knowledge of Matlab and ImageJ are desirable.