Blaszkiewicz Magdalena, Caron Lydia, Villinski Brooke, Passarelli Joshua, Towne Julia M, Story Naeemah M, Merchant Erin, Khan Furrukh S, Emanetoglu Nuri, Kass Leonard, Smith Rosemary L, Townsend Kristy L
Department of Neurological Surgery, The Ohio State University, Columbus, OH, United States.
School of Biology and Ecology, University of Maine, Orono, ME, United States.
Front Bioeng Biotechnol. 2025 Jan 10;12:1511383. doi: 10.3389/fbioe.2024.1511383. eCollection 2024.
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes. Proactive treatment options remain limited, which is exacerbated by a lack of sensitive and convenient diagnostics, especially early in disease progression or specifically to assess small fiber neuropathy (SFN), the loss of distal small diameter axons that innervate tissues and organs.
We designed, fabricated, tested, and validated a first-of-its-kind medical diagnostic device for the functional assessment of transdermal small fiber nerve activity. This device, the Detecting Early Neuropathy (DEN), is an electrically conductive needle array designed to record nerve electrical activity in the skin and subdermal tissues, as a feature of a broader theragnostic platform.
DEN recordings were validated across a time course of diet-induced PN in mice, using statistical and computational analyses and compared to other SFN measures. Based on these preclinical mouse data, the device design was adapted to obtain recordings in human with a flexible printed circuit board to mold to the leg or other skin regions. The DEN successfully recorded various types of neural activity in mouse and human, with or without stimulation, including validated action potentials and electromyography signals.
New functional diagnostic tools like DEN offer a promising outlook for patients needing an earlier or more sensitive diagnosis of DPN/SFN, to allow for earlier and more effective treatment options, especially as more become available in the clinic in future years.
糖尿病周围神经病变（DPN）是糖尿病常见的并发症。主动治疗方案仍然有限，缺乏灵敏便捷的诊断方法使这一情况更加恶化，尤其是在疾病进展早期或专门用于评估小纤维神经病变（SFN）时，即支配组织和器官的远端小直径轴突的丧失。
我们设计、制造、测试并验证了一种首创的用于经皮小纤维神经活动功能评估的医疗诊断设备。该设备名为早期神经病变检测仪（DEN），是一种导电针阵列，旨在记录皮肤和皮下组织中的神经电活动，作为更广泛的治疗诊断平台的一个特性。
使用统计和计算分析方法，在饮食诱导的小鼠周围神经病变的时间进程中对DEN记录进行了验证，并与其他小纤维神经病变测量方法进行了比较。基于这些临床前小鼠数据，对设备设计进行了调整，以使用柔性印刷电路板在人体腿部或其他皮肤区域进行记录。DEN成功记录了小鼠和人体在有或无刺激情况下的各种神经活动，包括经过验证的动作电位和肌电图信号。
像DEN这样的新型功能诊断工具为需要对DPN/SFN进行更早或更灵敏诊断的患者提供了一个有前景的展望，从而能够实现更早、更有效的治疗选择，特别是在未来几年临床中有更多此类工具可用的情况下。
