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

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.