The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch Sensation

颠簸：一种快速、非侵入性的触觉量化装置 摘要 好了！ 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。我们的目标是诊断周围神经病的发病附近，当可能的 逆转是最高的，并在治疗期间监测神经病变的进展或逆转。早些时候 发现功能受损的触摸比晚发现更有可能阻止或逆转神经病变 依靠神经退行性变的影响进行诊断的测试发现。 凸起是一个欺骗性的简单，外套口袋大小的装置，没有动力或移动部件， 在5-7分钟内量化手指触摸。该装置是一个光滑的表面，刻成棋盘状 方块。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硬币形状的粒子。 (凹凸不平)。受试者用手指键盘搜索每个方块的圆圈，寻找包含 一次颠簸。凹凸高度在每个方块中是不同的。这项测试是客观的，因为受试者必须找到隆起的位置 从几个可能的地点。凹凸不平的独特之处在于受试者不断地使用 疑似神经病的运动神经和感觉神经用指垫控制搜索 监控感官输入。其他的触觉测试都是主观的。例如，一名主考者触摸 皮肤用冯·弗雷单丝或探头，然后询问受试者他们是否感觉到探头，感觉到或没有感觉到 感觉到了。 在第一阶段，我们论证了该装置的可行性。在第二阶段，我们测试了健康对照受试者和 使用原始设备启动数据库的周围神经病患者的平均控制阈值 性别和年龄±性病。戴夫。以及客户使用的截止值作为标准，以与其 病人。在第二阶段开始时，我们与四家不同的公司合作，每家公司都使用他们的特殊技术 因为他们试图(但没有成功)建造出纳米级所需精度的凸起装置。 经过广泛的搜索，我们找到了10X Technology LLC，一家伊利诺伊州的公司，它有能力建造一种 将在第二阶段B中使用的主模，以一次一次大批量地生产最终凸起产品 为诊所、医院和其他医疗机构的提供者提供合理的价格。 第二阶段的目标是：1)制造一种面向市场的颠簸设备。2)将以下结果进行比较 新的颠簸装置的结果来自最初的磨砂玻璃原型#1在一个大队列中，3)确定了 新的BUPS设备区分健康和神经性疾病的敏感性和特异性 受试者；4)继续建立用于诊断的测试值和“截止”值的标准数据库 神经病；以及5)与营销合作伙伴合作将该设备商业化。资助期为24个月。

The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch Sensation Abstract ! Our proposal describes an elegant device called the Bumps that quantifies finger pad touch sensation 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. Early discovery of functionally impaired touch 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 finger pad touch in 5-7 minutes. The device is a smooth surface marked into checkerboard-like squares. Each square contains five colored circles. One circle in each square contains a tiny coin-shaped particle (a bump). Subjects search the circles of each square with the finger pad in search of the one circle that contains a bump. Bump height is different in each square. The test is objective because the subject must locate a bump from among several possible locations. The unique feature of the Bumps is that the subject continuously uses the very motor and sensory nerves suspected of being neuropathic to control the search with the finger pad and monitor the sensory input. Other tests of touch sensation are subjective. For example, an examiner touches the skin with a von Frey monofilament or probe, then asks the subject if they felt the probe, yes or no, felt or not felt. In Phase I, we demonstrated feasibility of the device. In Phase II, we tested healthy control subjects and subjects with peripheral neuropathy with the original device to start 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. At the onset of Phase II, we worked with four different companies each using their special techniques as they attempted (unsuccessfully) to construct a Bumps device with the precision required at nanometer levels. After an extensive search, we found 10X Technology LLC, an Illinois company that is capable of constructing a master mold that will be used in Phase IIB to produce the final Bumps product in larger quantities at a reasonable price for providers in clinics, hospitals and other health care settings. Phase IIB goals are: 1) Construct a market-ready Bumps device. 2) Compare the results obtained from the new Bumps device with results from the original ground-glass prototype #1 in a large cohort, 3) determine the sensitivity and specificity of the new Bumps device to discriminate between healthy and neuropathic subjects; 4) continue to develop a normative database of test values and “cut off” values for diagnosis of neuropathy; and 5) Work with a marketing partner to commercialize the device. The grant period is 24 months.