The broader impact/commercial potential of this Small Business Technology Transfer Research (STTR) Phase I project is to optimize and validate a novel medical device for early detection and diagnosis of peripheral neuropathy (PN). PN is damage of nerve fibers, typically starting in the skin and distal limbs and migrating to deeper tissue layers as the disease progresses, and affecting an estimated 30 million people. Currently no diagnostic tool nor cure exists, but early detection affords the possibility of slowing disease progression. The goal of this project is to advance the development of a small, cost-effective, portable microneedle device measuring nerve conductance, the only method to directly determine nerve function and determine the most accurate assessment of peripheral nerve health. This device addresses the need for a non-invasive, painless, early onset neuropathy diagnostic device for use in a clinical setting. The proposed STTR Phase I project will develop a novel medical device using an array of modified microneedle electrodes to measure nerve conductance in small nerve fibers of skin and underlying tissues. The project goals include: 1) reproducibly recording nerve conductance across an entire needle array and averaging signals using mathematical algorithms to interpret nerve signals for an assessment of neuropathic state; 2) determining the necessity of electrical stimulation for detecting nerve conductance; 3) optimizing signal amplification for an appropriate signal-to-noise ratio; 4) determining optimal needle specifications; and 5) developing wireless communication of the recorded signal and software for signal processing and transmission. Optimization of signal:noise ratio, signal amplification, needle specification and determination of the need for electrical stimulation will be done utilizing healthy animal models. Utilizing validated animal models of peripheral neuropathy, device measurements will be compared to nerve conductance velocity (to diagnose advanced PN) and standard (indirect) assessments of PN, including quantitative assessment of tactile allodynia (Von Frey test), behavioral assays (acetone spray test, hot/cold plate assay), and tissue biopsies. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
