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）：本申请描述了一种优雅简单的口袋大小的设备，称为“Bumps”，它可以快速量化手指上触摸的重要感觉，以微米（μm）为单位。这种高灵敏度可以区分健康受试者之间存在的触觉的微小变化，并且可以检测周围神经病变患者手指触觉的轻微减弱。颠簸的目的是尽早诊断神经病变，而逆转的可能性最高；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，其程度目前是不可能的。凹凸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指腹检测到的一系列分级粒子中的最小粒子（凹凸）。当受试者从几个可能的位置中找到一个凸起时，我们假设他们感觉到了。颠簸消除了耗时的强制选择是或否的方法。正常受试者在 10 分钟内即可找到高度 < 5 米的凹凸；孩子们只需不到3分钟。这种灵敏度超过了当前测试的灵敏度，可以及早发现神经损伤。在第一阶段，我们将构建一个新的 Bumps 设备原型，并通过测量一小群糖尿病患者（因为神经病变的高患病率）以及患有癌症的儿童和成人的触觉阈值来检测化疗引起的周围神经病变（CIPN）来展示其可行性。 CIPN 对于测试这种新设备特别有用，因为从化疗前假定感觉正常的患者到出现严重麻木的时间只有几个月。在此期间，可以以简短、成本有效的方式评估该装置用于早期检测神经病变和跟踪触摸灵敏度下降的效用。早期诊断对 CIPN 患者有益，因为它为治疗医生提供了在恢复潜力最大且出现神经毒性脑并发症之前尽早调整治疗的机会。此 STTR 是对 2009 年 3 月 NCI 报告的回应，该报告指出需要快速、灵敏、节省成本的方法来在当地家庭环境中测试 CIPN 患者。 公共健康相关性：Bumps 设备能够以微米级灵敏度快速、廉价且客观地测量手指的触觉。它将有助于在早期治疗成功的可能性最大时识别多种原因引起的周围神经病变，特别是糖尿病、癌症化疗和艾滋病毒。它将成为衡量新兴疗法有效性所需的新一代更灵敏的诊断测试之一。 STTR 第一阶段将用于制造一种新的原型设备，并由选定的知名机构的专家展示其在周围神经病中的实用性。