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STTR Phase I: Optimization of a device for peripheral nerve recordings to diagnose neuropathy

Award Information
Agency: National Science Foundation
Branch: N/A
Contract: 2014779
Agency Tracking Number: 2014779
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: BM
Solicitation Number: N/A
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-15
Award End Date (Contract End Date): 2021-05-31
Small Business Information
ORONO, ME 04473
United States
DUNS: 116899785
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 Magdalena Blaszkiewicz
 (617) 784-3459
Business Contact
 Magdalena Blaszkiewicz
Phone: (617) 784-3459
Research Institution
 University of Maine
 Kristy Townsend
5717 Corbett Hall
ORONO, ME 04469
United States

 Nonprofit college or university

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.

* Information listed above is at the time of submission. *

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