SBIR-STTR Award

Neuro Devices, Inc. will construct a dynamic sweat test (DST) for early detection of peripheral neuropathy. Neuropathy is detected by measuring the rate and volume of sweat secreted by single sweat glands (SGs) under the control of sudomotor nerves. The test has a major advantage over other tests of nerve function because SGs are accessible for analysis on distal sites of the hands and feet where the first signs of neuropathy appear. Device feasibility will be tested by comparing results from testing healthy control subjects and cancer patients with chemotherapy induced peripheral neuropathy (CIPN). Physicians at the M.D. Anderson hospital, Houston will add the DST to their extensive sensory testing of patients during chemotherapy that they perform to detect the initial signs of neuropathy. Early detection is beneficial because the potential for recovery declines with progressive nerve degeneration. Early diagnosis also provides the opportunity to decide if the chemotherapeutic agent should be decreased in dosage, discontinued, substituted or, when no neuropathy is detected, if chemotherapy can be increased to more effective cancer killing dosage. Existing sensory tests lack this sensitivity for early detection of minimal nerve abnormality. The dynamic sweat test (DST) device is a measure of the vitality of the sudomotor nerves that stimulate sweating. SGs whose nerves have degenerated cannot secrete water. Partially denervated and reinnervating SGs secrete smaller than normal sweat droplets. The DST measures SG density, distribution and total water volume. The DST also quantifies rate of sweating and amount of water of single SGs. This has an advantage over existing sweat tests that only measure total water produced at a skin location because sweating by normally secreting SGs can obscure a deficiency in a smaller number of partly or totally denervated SGs. In this sense the SG is the gateway to understanding the health of peripheral autonomic nerves.

Public Health Relevance:
Existing tests lack sensitivity to detect peripheral nerve disease early when it is most susceptible to treatment. Neuro Devices, Inc. will show that it is feasible to construct a device that can detect early signs of neuropathy in cancer patients with chemotherapy-induced neuropathy by measuring abnormalities of sweat rate and sweat volume secreted by individual sweat glands.

Thesaurus Terms:
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We devised a new generation, highly sensitivity method to diagnosis peripheral neuropathy early, when the probability for reversal is greatest. Cancer chemotherapy and diabetes are the most common causes of neuropathy in the USA. Both cause decreased sweating, abnormal circulation, peripheral numbness, pain and weakness. If diagnosed early, both are potentially treatable. Unfortunately, the minimal changes in function, that first signal impending neuropathy or response to treatment, escape detection by current tests. Early recognition would provide a better opportunity to treat, halt or reverse neuropathy than later discovery after significant nerve degeneration. Our sensitive sweat test (SST) detects early dysfunction of sudomotor nerves that activate sweat glands (SGs) by measuring the rate and volume of water secreted from each of > 200 individual SGs per image. The innovative feature of the SST was placement of starch-coated Scotch(R) tape on the iodine-coated skin. Tape forces the sweat droplets to flow centrifugally in a flat expanding spot made densely black by reaction of the sweat-wetted starch and iodine. The rate of expansion of the black spot is proportional to the sweat rate of that SG. Spot area is proportional to volume from the same SG. The sweat spots are imaged by miniature device at 1 image/sec for 90 seconds, counted and rates and volumes calculated. Each SG appears to have its own characteristic secretion rate. Dysfunction of secretion at the level of the single gland is an earler indicator of beginning neuropathy than the current QSART measure of total water/skin area. The SST appears capable of measuring progression of neuropathy and potential to record degrees of recovery by recording small incremental changes of sweat rate and volume from single SGs. The SST can make diagnosis and evaluation of neuropathy faster, more convenient and less expensive. Phase I has been highly successful. We constructed a compact, computer mouse size, sensitive device that we used to test controls and patients with diabetic and chemotherapy neuropathy. Sweat spot counts, their distribution, and individual SG rate and volume of water secreted correlated with severe neuropathy on the foot and calf. In Phase II we will construct a market-ready device that is convenient, affordable, hand held and easily used in medical clinics, at the bedside or in the home. We will obtain control values from large numbers of healthy persons and test patients with CIPN, diabetic neuropathy and other neuropathies in MN and from three collaborating institutions. Commercialization will be in partnership with the WR Co Inc. a MN medical device company that markets other medical devices.

Public Health Relevance Statement:


Public Health Relevance:
Neuro Devices will manufacture, test and market a miniature highly sensitive sweat test (SST) device to measure rate and nano liter volumes of sweat secreted by > 200 single sweat glands for earlier diagnosis and detection of progression or recovery with treatment, of patients with chemotherapy-induced, diabetic and other neuropathies.

Project Terms:
Area; Biopsy; Blood Circulation; Breast; Characteristics; chemotherapeutic agent; chemotherapy; Chemotherapy-Oncologic Procedure; Clinic; Clinical; Colon; commercialization; Computer software; Computers; Contracts; cost effective; Databases; Denervation; density; Detection; Devices; Diabetes Mellitus; diabetic; Diabetic Neuropathies; Diagnosis; diagnosis evaluation; Drops; Early Diagnosis; Etiology; Evaluation; Evolution; experience; expiration; Feasibility Studies; foot; Functional disorder; Generations; Gland; Goals; Hand; healthy volunteer; Home environment; Image; improved; Individual; innovation; Institution; instrument; Iodine; Iontophoresis; Laboratory Research; Lead; Learning; Marketing; Measurement; Measures; Medical; Medical Device; Methods; miniaturize; Mus; nanolitre; Nerve; Nerve Degeneration; Neuropathy; Normal Range; novel; Numbness; Pain; Patients; Pattern; Peripheral; Peripheral Nervous System Diseases; Persons; Phase; Physicians; Probability; Protective Agents; prototype; public health relevance; Reaction; Recovery; rectal; response; Running; Sensory; Severities; Signal Transduction; Skin; Spottings; Staging; Starch; success; Sweat; Sweat Glands; Sweat test; Sweating; Symptoms; Testing; Time; Translating; Water