The SweatC system is a programmable electro medical device comprised of a USB plug and play hardware unit (electronic box, cables, and 2 disposable electrodes), and software for the measurement of galvanic skin response.
The SweatC measurement process uses the electrically induced quantitative sudomotor axon reﬂex tests method following DC stimulation at constant voltage of 1.28V, and provides quantitative evaluation of the sweat response measured on disposable electrodes .The quantitave induced sweat response is expressed in skin voltage response (SVR). The measurement is performed at the sole of the right and left feet, which have the highest density of eccrine sweat glands and C-fibers that travel the furthest from the brain and spinal cord.
Sudomotor dysfunction has been found in diabetic patients, medication side effects such as cancer treatment or antihypertensive treatment ( in particular Beta and Alpha blockers, and calcium antagonists), Metformin treatment, vitamin D or B12 deficiency, Parkinson’s disease, AISD, amyotrophic lateral sclerosis, hypothyroidism, kidney and liver diseases, alcoholism, Alzheimer's disease and Guillain-Barre syndrome.
The Sudomotor test evaluates autonomic function (the sympathetic cholinergic division) , and it is performed in a clinical setting to evaluate and document neuropathic disturbances that may be associated with pain or symptoms. Examples of Sudomotor testing include: The quantitative sudomotor axon reflex test (QSART), thermoregulatory sweat test (TST), sympathetic or galvanic skin responses, and silastic sweat imprints are tests of sympathetic cholinergic sudomotor function.
There exists over 60 years of data supporting the use of sudomotor testing in clinical practice, and the Sudomotor testing clinical data suggest it may be the most sensitive means to detect peripheral small fiber neuropathy (Low, et al.,2006) The exam is performed in supine position on exam table.
The use of large disposable (single use) electrodes prevents:
FDA Clearance 510K number k152216