Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction

Background: Therapeutic focused ultrasound (TFU) is rapidly emerging as a non-invasive precision medical intervention targeting the brain, with applications ranging from thermal ablation, BBB opening for drug delivery or gene transfection, and neuromodulation. Though safety standards for diagnostic use of ultrasound have been well established, its application in TFU is still questionable, as the latter requires higher intensities and longer application.  Updated guidance on the safety assessment is urgently needed to standardize the regulation of such devices and expedite its access to the patients.

Research Plan: The primary goal of this proposal is to develop Develop risk estimation tool(s) for focused ultrasound devices at different parameter levels with brain indications. The expected deliverables of this project include 1) a regulatory science tool that defines the safety and effectiveness boundaries for sponsors to design brain therapeutic paradigms through identifying relationship curves of cellular response and ultrasound parameters; 2) a refined non-clinical testing battery (i.e., in vitro, behavioral, and histopathological testing) for measuring adverse effects of ultrasound brain therapy.

Prerequisites: An introductory course in neuroscience, knowledge of ultrasound engineering and Matlab and ImageJ are desirable.