The Bumps ad device for rapid non invasive quantification of touch sensation

用于快速无创量化触觉的 Bumps 广告设备

• 批准号: 8730251
• 负责人: WILLIAM R KENNEDY
• 金额: $ 68.14万
• 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: 2012-09-04 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8730251
• 关键词: Address; Age; Auditory; Blood Vessels; Brain; Caliber; Coin; Colon; Color; Confocal Microscopy; Contracts; Data Collection; Databases; Deposition; Devices; Diabetes Mellitus; Diagnosis; Diagnostic tests; Early Diagnosis; Esthesia; Feeling; Fingerprint; Fingers; Functional disorder; Generations; Goals; Height; Image; Institution; Instruction; Laboratories; Location; Marketing; Measures; Medical Device; Meissners Corpuscle; Methods; Minnesota; Molds; Monitor; Nerve; Nerve Degeneration; Nerve Fibers; Neurologic; Neurologic Examination; Neuropathy; Numbness; Pain; Pathology; Patients; Peripheral Nervous System Diseases; Persons; Phase; Production; Protocols documentation; Publications; Rectal Cancer; Sales; Sensory; Shapes; Signal Transduction; Skin; Staging; Surface; Sweat; Sweating; Symptoms; Tactile; Testing; Time; Touch sensation; Universities; Validation; Visual; Work; chemotherapy; density; design; diabetic; distraction; effectiveness measure; functional disability; malignant breast neoplasm; member; particle; public health relevance; receptor; sex

DESCRIPTION (provided by applicant): Our proposal describes an elegant device called the Bumps that quantifies touch sensation on the fingers at low micron levels. The objectives are to diagnose peripheral neuropathy near its onset, when the possibility for reversal is highest, and to monitor either progression or reversal of neuropathy during treatment. Target neuropathies are those related to chemotherapy and diabetes. Both are potentially treatable if diagnosed early. Common symptoms are numbness, pain, weakness, decreased sweating and impaired vascular function. We propose that early discovery of functionally impaired touch with the Bumps provides a better chance to halt or reverse neuropathy than later discovery by tests that rely on the effects of nerve degeneration for diagnosis. The Bumps is a deceivingly simple, coat pocket size device without power or moving parts that quantifies touch of the fingerpad in a few minutes. The device is a smooth surface marked into several squares, much like a checkerboard. Each square contains five colored circles. One circle in each square contains a tiny particle (bump). Bumps are shaped like thin flattened cylinders. Subjects search the 5 circles of a square with the fingerpad much like feeling skin or any surface. The task is to find the one circle in the square that contains a bump; each square is explored in turn. Bump height is different in each square. When a subject locates a bump there is no need to ask if they felt it. This requirement to locate a bump makes the test objective. When the finger contacts a bump the fingerprint ridges become slightly distorted and activate underlying Meissner Corpuscles (MCs) touch receptors that are lined along the fingerprint ridges. The MCs relay sensation to the brain for recognition. The absence of a time restriction allows multiple passes over the 5 circles providing opportunity for temporal and spatial summation not possible with methods that measure tactile sense by touching skin with a von Frey monofilament or probe. In Phase I we demonstrated feasibility of the device. Phase II goals are: 1) to test healthy subjects and neuropathy patients and build a database with mean control thresholds for sex and age ¿ std. dev. and cutoff values for customers to use as standards to compare with results from their patients; 2) to test patients frequently during chemotherapy to show the Bumps ability for early diagnosis and for detecting increments of progression of neuropathy; 3) further validation by correlating Bumps results with the density of finger MCs touch receptors counted in reflectance confocal microscopy images of the tested finger; and 4) construction of a master mold to manufacture inexpensive market ready Bumps devices. Phase II goals will be accomplished by contract with the U of MN Kennedy laboratory (KLAB), and via KLAB with expert collaborators at three other major institutions to incorporate Bumps testing in their protocols to enlarge the number of subjects tested.

描述（由申请人提供）：我们的提案描述了一种称为Bumps的优雅设备，其以低微米级量化手指上的触觉。其目的是诊断周围神经病变发作时，逆转的可能性是最高的，并监测治疗期间的进展或逆转的神经病变。目标神经病变是与化疗和糖尿病相关的神经病变。如果早期诊断，两者都是可以治疗的。常见的症状是麻木、疼痛、虚弱、出汗减少和血管功能受损。我们认为，早期发现功能受损的触摸与颠簸提供了一个更好的机会，停止或逆转神经病变比后来发现的测试，依赖于神经变性的影响进行诊断。Bumps是一个简单得令人难以置信的外套口袋大小的设备，没有电源或移动部件，可以在几分钟内量化手指垫的触摸。该设备是一个光滑的表面标记成几个正方形，很像一个棋盘。每个正方形包含五个彩色圆圈。每个正方形中的一个圆包含一个微小的粒子（凸起）。凸块的形状像扁平的圆柱体。受试者用手指垫搜索正方形的5个圆圈，就像感觉皮肤或任何表面一样。任务是在正方形中找到一个包含凹凸的圆;依次探索每个正方形。每个方块的凹凸高度不同。当受试者找到肿块时，没有必要问他们是否感觉到了。 定位凸块的这一要求成为测试目标。当手指接触凸起时，指纹脊变得稍微扭曲，并激活下面的迈斯纳小体（MC）触摸感受器，其沿指纹脊沿着。MC将感觉传递给大脑进行识别。没有时间限制允许在5个圆上多次通过，提供了时间和空间求和的机会，这对于通过用von Frey单丝或探针接触皮肤来测量触觉的方法是不可能的。在第一阶段，我们证明了该设备的可行性。第二阶段的目标是：1）测试健康受试者和神经病患者，并建立一个数据库，其中包括性别和年龄的平均控制阈值。dev.和截止值，供客户用作标准以与来自其患者的结果进行比较; 2）在化疗期间频繁地测试患者以显示Bumps用于早期诊断和用于检测神经病变进展的增量的能力; 3）通过将Bumps结果与在测试手指的反射共聚焦显微镜图像中计数的手指MC触摸感受器的密度相关联来进一步验证;以及4）构造母模以制造廉价的市场上现成的凸块器件。第二阶段的目标将通过与明尼苏达大学肯尼迪实验室（KLAB）的合同来实现，并通过KLAB与其他三个主要机构的专家合作者将Bumps测试纳入其协议中，以扩大测试的受试者数量。