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名为凸起的优雅设备，它可以在低微米级别量化手指上的触摸感觉。其目的是诊断周围神经病变的发病临近，当逆转的可能性是最高的，并监测神经病变的进展或逆转在治疗期间。靶向神经疾病是那些与化疗和糖尿病相关的疾病。如果及早诊断，这两种疾病都有可能治愈。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，与依靠神经变性影响进行诊断的测试相比，早期发现功能受损的肿块触摸提供了更好的停止或逆转神经病变的机会。凸起是一种简单得令人难以置信的外套口袋大小的设备，没有电力或活动部件，可以在几分钟内量化指垫的触摸。该设备是一个光滑的表面，被标记成几个正方形，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(凹凸)。凸起的形状像薄的扁平的圆柱体。受试者用指垫搜索正方形的5个圆圈，就像触摸皮肤或任何表面一样。任务是找到正方形中包含凹凸的一个圆圈；每个正方形都依次进行探索。凹凸高度在每个方块中是不同的。当受试者定位到凸起时，没有必要问他们是否感觉到了。 这种定位凸块的要求使测试成为目标。当手指接触凸起时，指纹脊会轻微扭曲，激活沿着指纹脊线排列的触觉感受器下的迈斯纳小体。MC将感觉传递给大脑进行识别。没有时间限制，允许在5个圆圈上多次通过，提供了时间和空间求和的机会，这是通过用冯·弗雷单丝或探头触摸皮肤来测量触觉的方法所不可能的。在第一阶段，我们论证了该装置的可行性。第二阶段的目标是：1)测试健康受试者和神经病患者，并建立一个性别和年龄的平均控制阈值数据库。戴夫。和客户的临界值作为标准，以与他们的患者的结果进行比较；2)在化疗期间经常对患者进行测试，以显示BUPS对早期诊断和检测神经疾病进展的增量的能力；3)通过将BUPS结果与被测试手指的反射共焦显微镜图像中所计数的手指MC触摸感受器的密度相关联来进一步验证；以及4)构建一个母模，以生产廉价的市场上可用的BUPS设备。第二阶段的目标将通过与明尼苏达大学肯尼迪实验室(KLab)签订合同来实现，并通过kLab与其他三家主要机构的专家合作者合作，将凸起测试纳入他们的方案中，以扩大测试对象的数量。

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.