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

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，可以在低微米水平上量化手指的触摸感觉。目的是在发病附近诊断周围神经病变，此时逆转的可能性最高，并在治疗期间监测神经病变的进展或逆转。目标神经病变是那些与化疗和糖尿病有关的神经病变。如果及早诊断，这两种疾病都是可以治疗的。常见的症状是麻木、疼痛、虚弱、出汗减少和血管功能受损。我们建议，早期发现功能受损的触摸肿块提供了更好的机会来停止或逆转神经病变，而不是后来通过依赖于神经变性的检测来诊断。Bumps是一个看似简单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板的触摸。该装置是一个光滑的表面，标记成几个正方形，很像棋盘。每个正方形包含五个彩色圆圈。每个正方形中的一个圆圈包含一个微小的粒子（凸起）。凸起的形状像扁平的薄圆柱体。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肿块的圆；每个方块依次探索。每个方格的凹凸高度是不同的。当实验对象定位到一个肿块时，不需要问他们是否感觉到它。

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.