"Speed Bumps": A non-invasive quantitative test for early detection of neuropathy in the feet

“Speed Bumps”：早期发现足部神经病变的非侵入性定量测试

基本信息

批准号：
9202599
负责人：
WILLIAM R KENNEDY
金额：
$ 21.02万
依托单位：
NEURO DEVICES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-01 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9202599
关键词：
Adult Aging Area Automobile Driving Biomedical Engineering Biopsy Burning Pain Caliber Cancer Patient Centers for Disease Control and Prevention (U.S.)Chemotherapy-Oncologic Procedure Chemotherapy-induced peripheral neuropathy Clinic Clinical Complications of Diabetes Mellitus Degenerative Disorder Dermal Dermis Device Designs Devices Diabetes Mellitus Diabetic Neuropathies Diagnosis Distal Early Diagnosis Early treatment Effectiveness Elderly Equilibrium Esthesia Fingers Frequencies Generations Goals Gossypium Hand Height Hockey Home environment Individual Industry Judgment Length Maintenance Measures Medical Device Meissners Corpuscle Methods Molecular Biology Molecular Genetics Monitor Motor Names Nanotechnology Nerve Neural Conduction Neurologic Examination Neurons Neuropathy Nociception Numbness Nutrient Pacinian Corpuscles Parents Patients Peripheral Nerves Peripheral Nervous System Diseases Persons Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Physicians Recovery Reporting Research Safety Sensory Sensory Thresholds Severities Shapes Skin Small Business Technology Transfer Research Speed Spinal Cord Spinal Ganglia Stimulus Surface Sweat Sweat Glands Sweat test Sweating Symptoms Tactile Testing Thick Time Toes Touch sensation Variant afferent nerve autonomic nerve base chemotherapy cohort cost cost efficient design design and construction diabetic experience follow-up foot improved indexing instrument member neurotoxic novel therapeutics painful neuropathy particle prevent prototype receptor response tool vibration

项目摘要

ABSTRACT This STTR Phase I resubmission describes a small, deceptively simple, portable device, called “Speed Bumps” that rapidly quantifies the sensation of flutter on the feet, toes or fingers in micrometer (µm) units. Flutter frequency is 20 to 30 Hz, which is below the approximate lower vibration range of 40 to 50 Hz. This high sensitivity device is designed to differentiate the small variations of flutter sensation that exist between healthy subjects and detect the reduction of sensation in the feet of persons with peripheral neuropathy. The Speed Bumps device is designed to diagnose neuropathy very early, when the potential for reversal is highest; and to monitor the effectiveness of new therapies appearing from research in molecular genetics, pharmacology, nanotechnology and other exciting fields to a degree that is not now possible. The device is a slender plastic ruler with groups of raised parallel ridges of different heights placed perpendicular to its length. Heights of the groups of ridges range from a high of 40 µm to a low of 1 µm. Rubbing the ridges to and fro on the skin creates a flutter sensation that mimics the body sensations produced by highway speed bumps or rumble strips. The large skin area contacted by groups of different height ridges creates a range of stimulus strengths, from barely detectable as needed to measure the threshold stimulus of the toes of healthy persons to a stronger stimulus by the highest ridges that can be recognized by patients with severe neuropathy. Flutter excites the Meissner corpuscle (MC) receptors in the superficial dermis that are important receptors for balance maintenance during many daily activities. We define the flutter threshold as the smallest set of ridges that can be detected by the foot, toes, or fingers. Normal subjects detect ridge heights <8 µm on the fingers in < 20 seconds and <8 µm on the feet and toes in 60 seconds. This sensitivity exceeds that of current tests and allows rapid early detection and grading of nerve damage. In Phase I we will build a new prototype of the Speed Bumps device and show feasibility by measuring the flutter thresholds of small cohorts of healthy adults and of patients with diabetic neuropathy and chemotherapy induced peripheral neuropathy (CIPN). CIPN is especially useful for testing this new device because the time elapsed between the patient having presumed normal sensation before chemotherapy and developing severe numbness during therapy occurs within weeks. This allows us to test the device during progression of neuropathy in a short, cost efficient study. Early diagnosis is beneficial for CIPN patients because it gives treating physicians an early opportunity to modify treatment at a time when the potential for recovery is greatest and before the onset of painful neuropathy prevents continuation of treatment. This STTR project responds to a March 2009 NCI report that cites a need for rapid, sensitive, cost saving methods to test patients with CIPN in their local home environment.

抽象的此sttr阶段I重新提交描述了一个小的，欺骗性的简单，便携式设备，称为 “速度颠簸”迅速量化了脚上颤动的感觉千分尺（µm）单位。颤音频率为20至30 Hz，低于近似较低的频率振动范围为40至50 Hz。这种高灵敏度设备旨在区分小型健康受试者之间存在的颤音感觉的变化并检测患有周围神经病的人脚的感觉。速度颠簸设备旨在很早地诊断神经病，当逆转最高；并监测研究中新疗法的有效性分子遗传学，药理学，纳米技术和其他令人兴奋的领域，不是现在可能。该设备是一个细长的塑料标尺垂直于其长度。一组脊的高度从40 µm到低1的高度 µm。在皮肤上摩擦山脊，并在皮肤上摩擦会产生一种模仿身体的颤动的感觉高速公路速度颠簸或隆隆声带产生的感觉。大型皮肤区域与不同高度脊的组创造了一系列刺激强度，从几乎无法检测到需要测量健康人脚趾的阈值刺激，以实现更强的刺激严重神经病患者可以识别的最高脊。颤动激发浅表真皮中的Meissner Corpuscle（MC）受体是重要的受体在许多日常活动中进行维护。我们将颤动阈值定义为最小的山脊，脚，脚趾，或手指。正常受试者在<20秒内检测到手指上的山脊高度<8 µm，<8 µm <8 µm 脚和脚趾在60秒内。这种敏感性超过了当前测试的灵敏度，并允许快速快速神经损伤的检测和分级。在第一阶段，我们将构建一个新的速度颠簸设备的原型，并通过测量一小部分健康成年人和糖尿病患者的颤动阈值神经病和化学疗法诱导周围神经病（CIPN）。 CIPN对于测试这个新设备，因为假定正常的患者之间经过的时间在化疗前的感觉和治疗过程中发生严重麻木性发生几周。这使我们能够在短暂，成本效益的神经病进展过程中测试设备学习。早期诊断对CIPN患者是有益的，因为它使治疗医生早期在恢复潜力最大的时候修改治疗的机会疼痛神经病的发作可阻止治疗的继续。该STTR项目响应2009年3月的NCI报告，该报告需要快速，敏感，成本节省方法在当地的家庭环境中测试患者CIPN的方法。