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: 9913601
• 负责人: WILLIAM R KENNEDY
• 金额: $ 84.68万
• 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 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9913601
• 关键词: Address; Adult; Age; Auditory; Biopsy; Boston; Caliber; Cancer Center; Chemotherapy-induced peripheral neuropathy; Clinics and Hospitals; Coin; Color; Data; Databases; Deposition; Detection; Devices; Diabetes Mellitus; Diabetic Neuropathies; Diagnosis; Dimensions; Disease; Early Diagnosis; Fingers; General Hospitals; Generations; Glass; Goals; Grant; Hand; Height; Human; Illinois; Institution; Instruction; Location; Marketing; Massachusetts; Measures; Medical Device; Meissners Corpuscle; Methods; Minnesota; Molds; Monitor; Motor; Nerve Degeneration; Neuropathy; Patients; Peripheral Nervous System Diseases; Persons; Pharmacologic Substance; Phase; Price; Provider; Secondary to; Sensitivity and Specificity; Sensory; Severities; Skin; Standardization; Stimulus; Structure; Stuttering; Surface; Tactile; Techniques; Technology; Testing; Thick; Touch sensation; Universities; Validation; Visual; Work; afferent nerve; chemotherapy; cohort; commercialization; density; design; distraction; effectiveness evaluation; functional disability; health care settings; improved; indexing; member; nano; nanometer; nervous system disorder; novel; particle; phase 2 testing; prototype; receptor; reflectance confocal microscopy; response; sensory input; sex; touchpad

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.

The Bumps：一种快速、非侵入性量化触觉的设备 抽象的 ！ 我们的提案描述了一种名为 Bumps 的优雅设备，它可以量化手指垫的触摸感觉 低微米水平。目的是在周围神经病发病时诊断出周围神经病的可能性 逆转最高，并在治疗期间监测神经病变的进展或逆转。早期的 触摸功能受损的发现为阻止或逆转神经病变提供了比后来更好的机会 通过依靠神经变性的影响进行诊断的测试来发现。 Bumps 是一款看似简单、外套口袋大小的设备，没有电源或移动部件， 在 5-7 分钟内量化指垫触摸。该装置是一个光滑的表面，被标记成棋盘状 正方形。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颗粒 （一个肿块）。受试者用指腹搜索每个正方形的圆圈，寻找包含以下内容的圆圈： 一个肿块。每个方块中的凹凸高度不同。该测试是客观的，因为受试者必须找到一个肿块 从几个可能的位置中选择。凹凸的独特之处在于对象不断地使用 被怀疑是神经病的运动神经和感觉神经控制着指腹的搜索 监测感觉输入。其他触觉测试是主观的。例如，考官触摸 用冯弗雷单丝或探针接触皮肤，然后询问受试者是否感觉到探针，是或否，感觉到或没有 毛毡。 在第一阶段，我们展示了该设备的可行性。在第二阶段，我们测试了健康对照受试者和 患有周围神经病变的受试者使用原始设备启动一个具有平均控制阈值的数据库 性别和年龄±标准。开发人员。和截止值供客户用作标准来与他们的结果进行比较 患者。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 他们试图（未成功）构建具有纳米级精度要求的凹凸器件。 经过广泛的搜索，我们找到了 10X Technology LLC，一家伊利诺伊州公司，能够建造一个 主模具将在 IIB 阶段使用，以大批量生产最终的 Bumps 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。 IIB 阶段的目标是： 1) 构建一个可投入市场的 Bumps 器件。 2）比较得到的结果 新的 Bumps 设备与一大群中原始毛玻璃原型 #1 的结果，3) 确定 新型 Bumps 设备区分健康和神经病变的敏感性和特异性 科目； 4) 继续开发测试值和诊断“截止”值的规范数据库 神经病； 5) 与营销合作伙伴合作将设备商业化。资助期限为24个月。