This application describes an elegantly simple, pocket size device, called "the Bumps" that rapidly quantifies the important sensation of touch on the fingers in micrometer (?m) units. This high sensitivity differentiates the small variations f touch sensation that exist between healthy subjects and can detect minor reduction of touch sensation in fingers of persons with peripheral neuropathy. The purposes of the Bumps are to diagnose neuropathy very early, while the potential for reversal is highest;and to monitor the effectiveness of new therapies appearing from research in molecular genetics and other exciting fields, to a degree not now possible. The Bumps measure the touch threshold of Meissner corpuscle receptor organs on the fingerprint ridges. We define touch threshold as the smallest particle (bump) in a graduated series of particles that subjects can detect with the finger pad. When subjects locate a bump from among several possible locations we assume they felt it. The Bumps eliminates the time consuming forced choice, yes or no, method. Normal subjects locate bumps of <5 ?m height in less than 10 minutes;children in less than 3 minutes. This sensitivity exceeds that of current tests and allows early detection of nerve damage. In Phase I we will build a new prototype Bumps device and show feasibility by measuring tactile thresholds of small cohorts of patients with diabetes (because of the high prevalence of neuropathy) and of children and adults with cancer to detect chemotherapy induced peripheral neuropathy (CIPN). CIPN is especially useful for testing this new device because the time elapsed between the patient having presumed normal sensation before chemotherapy to developing severe numbness is only a few months. During this time the utility of the device for early detection of neuropathy and for following the decline of touch sensitivity can be evaluated in a short, cost efficient, manner. Early diagnosis is beneficial for CIPN patients because it gives treating physicians an early opportunity to modify treatment at a time when the potential for recovery is greatest and before neurotoxic cerebral complications appear. This STTR responds to a March 2009 NCI report that cites a need for rapid, sensitive, cost saving methods to test patients with CIPN in their local home environment.
The Bumps device quickly, inexpensively and objectively measures touch sensation of fingers with micrometer sensitivity. It will be useful for recognition of peripheral neuropathy, from many causes, especially diabetes, cancer chemotherapy and HIV, early when the potential for therapeutic success is highest. It will be one of a new generation of more sensitive diagnostic tests needed to measure effectiveness of new emerging therapies. This STTR Phase I will be used to manufacture a new prototype device and to show feasibility for its utility in peripheral neuropathy by specialists at selected high profile instittions.