The Bumps, a device for rapid, non invasive quantification of touch sensation

The Bumps，一种快速、非侵入性量化触觉的设备

• 批准号: 8314944
• 负责人: WILLIAM R KENNEDY
• 金额: $ 19.09万
• 依托单位: NEURO DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314944
• 关键词: Adult; Affect; Alcohols; Caliber; Cerebrum; Chemotherapy-Oncologic Procedure; Child; Clinics and Hospitals; Coin; Color; Data; Dermis; Detection; Devices; Diabetes Mellitus; Diagnosis; Diagnostic tests; Early Diagnosis; Effectiveness; Esthesia; Feasibility Studies; Fingerprint; Fingers; Generations; Genetic; Goals; HIV; Hand; Health Personnel; Height; High Prevalence; Home environment; Home visitation; House Call; Human; Life; Location; Malignant Neoplasms; Marketing; Measures; Meissners Corpuscle; Methods; Minor; Molecular Biology; Molecular Genetics; Monitor; Nanotechnology; Nerve; Neuropathy; Numbness; Organ; Patients; Performance; Peripheral Nervous System Diseases; Persons; Pharmacology; Phase; Physicians; Physicians' Offices; Polyneuropathy; Public Health; Recovery; Reporting; Research; Self Care; Sensory; Series; Shapes; Skin; Small Business Technology Transfer Research; Specialist; Surface; Symptoms; Tactile; Testing; Therapeutic; Time; Touch sensation; Variant; chemotherapy; cohort; cost; cost effective; cost efficient; design; design and construction; diabetic; dosage; effectiveness measure; feeding; member; neurotoxic; novel strategies; particle; prototype; receptor; response; success; symposium; tool

DESCRIPTION (provided by applicant): This application describes an elegantly simple, pocket size device, called "the Bumps" that rapidly quantifies the important sensation of touch on the fingers in micrometer (¿m) units. This high sensitivity differentiates the small variations f touch sensation that exist between healthy subjects and can detect minor reduction of touch sensation in fingers of persons with peripheral neuropathy. The purposes of the Bumps are to diagnose neuropathy very early, while the potential for reversal is highest; and to monitor the effectiveness of new therapies appearing from research in molecular genetics and other exciting fields, to a degree not now possible. The Bumps measure the touch threshold of Meissner corpuscle receptor organs on the fingerprint ridges. We define touch threshold as the smallest particle (bump) in a graduated series of particles that subjects can detect with the finger pad. When subjects locate a bump from among several possible locations we assume they felt it. The Bumps eliminates the time consuming forced choice, yes or no, method. Normal subjects locate bumps of < 5 ¿m height in less than 10 minutes; children in less than 3 minutes. This sensitivity exceeds that of current tests and allows early detection of nerve damage. In Phase I we will build a new prototype Bumps device and show feasibility by measuring tactile thresholds of small cohorts of patients with diabetes (because of the high prevalence of neuropathy) and of children and adults with cancer to detect 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 to developing severe numbness is only a few months. During this time the utility of the device for early detection of neuropathy and for following the decline of touch sensitivity can be evaluated in a short, cost efficient, manner. 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 neurotoxic cerebral complications appear. This STTR 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. PUBLIC HEALTH RELEVANCE: The Bumps device quickly, inexpensively and objectively measures touch sensation of fingers with micrometer sensitivity. It will be useful for recognition of peripheral neuropathy, from many causes, especially diabetes, cancer chemotherapy and HIV, early when the potential for therapeutic success is highest. It will be one of a new generation of more sensitive diagnostic tests needed to measure effectiveness of new emerging therapies. This STTR Phase I will be used to manufacture a new prototype device and to show feasibility for its utility in peripheral neuropathy by specialists at selected high profile instittions.

描述（由申请人提供）：此应用程序描述了一种优雅简单，口袋大小的设备，称为“肿块”，可以快速量化以微米（¿m）为单位的手指触摸的重要感觉。这种高灵敏度可以区分健康受试者之间存在的微小触觉变化，并可以检测周围神经病变患者手指的轻微触觉减少。Bumps的目的是在早期诊断神经病变，而逆转的可能性是最高的；并监测分子遗传学和其他令人兴奋的领域研究中出现的新疗法的有效性，达到目前不可能达到的程度。凸起测量指纹脊上迈斯纳小体受体器官的触摸阈值。我们将触摸阈值定义为受试者可以用手指垫检测到的一系列渐变粒子中最小的粒子（碰撞）。当实验对象在几个可能的位置中找到一个凸起时，我们假设他们感觉到它。Bumps消除了耗时的强迫选择是或否的方法。正常受试者在不到10分钟内找到高度< 5¿m的肿块；孩子在3分钟内。这种灵敏度超过了目前的测试，可以早期发现神经损伤。在第一阶段，我们将建立一个新的Bumps设备原型，并通过测量小队列糖尿病患者（因为神经病变的高患病率）以及儿童和成人癌症患者的触觉阈值来检测化疗诱导的周围神经病变（CIPN）来证明其可行性。CIPN对于测试这种新装置特别有用，因为从患者在化疗前感觉正常到发展为严重麻木的时间只有几个月。在此期间，该设备用于早期检测神经病变和跟踪触摸灵敏度下降的效用可以以一种简短，经济有效的方式进行评估。早期诊断对CIPN患者是有益的，因为它使治疗医生有机会在康复潜力最大和出现神经毒性脑并发症之前尽早调整治疗。该STTR是对2009年3月NCI报告的回应，该报告指出需要快速、敏感、节省成本的方法在当地家庭环境中检测CIPN患者。