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

这个小型企业技术转移研究(STTR)第一阶段项目的更广泛的影响/商业潜力是优化和验证一种用于早期检测和诊断周围神经病变(PN)的新型医疗设备。PN是神经纤维的损伤，通常始于皮肤和四肢远端，随着疾病的进展迁移到更深的组织层，估计有3000万人受到影响。目前还没有诊断工具或治愈方法，但早期检测提供了减缓疾病进展的可能性。该项目的目标是推动开发一种小型、高性价比、便携式的微针设备来测量神经电导，这是直接确定神经功能和确定最准确的周围神经健康评估的唯一方法。该设备满足了临床环境中使用的非侵入性、无痛、早期发病的神经病诊断设备的需求。拟议的STTR第一阶段项目将开发一种新型医疗设备，使用一系列改进的微针电极来测量皮肤和底层组织的小神经纤维中的神经电导。该项目的目标包括：1)重复记录整个针头阵列上的神经电导，并使用数学算法对信号进行平均，以解释神经信号以评估神经病变状态；2)确定检测神经电导是否需要电刺激；3)优化信号放大以获得适当的信噪比；4)确定最佳针头规格；以及5)开发记录信号的无线通信以及用于信号处理和传输的软件。优化信噪比、信号放大、针头规格和确定是否需要电刺激将利用健康的动物模型进行。利用经过验证的周围神经病变动物模型，设备测量将与神经传导速度(诊断晚期PN)和PN的标准(间接)评估进行比较，包括对触觉过敏的定量评估(Von Frey测试)、行为分析(丙酮喷雾测试、热/冷平板测试)和组织活检。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.