Sudomotor Autonomic Assessments

SudoCheck evaluates the function of sweat glands innervated by the peripheral system.

SudoCheck is a quick and non-invasive test to assess peripheral autonomic neuropathy.

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VitalScan SudoCheck


A Clinical Powerful Easy To Use Non-Invasive System, FDA 510K Cleared. In 5 Minutes Identify Patients at Risk.

VitalScan SudoCheck system helps clinicians with Peripheral Neuropathies and Sudomotor function evaluation. The assessment focuses on tiny nerve fibers within the autonomic nervous system, and their ability to quickly regenerate.

Small nerve fibers are the first victims of diabetes, which affects the peripheral nervous system even if symptoms remain sub-clinical. According to a recent study, already at an early stage of diabetes, the sympathetic innervation of eccrine sweat glands density and function is progressively reduced.
VitalScan SudoCheck has been created to enable a precise evaluation of sweat gland function. Based on a measuring method, patients place their hands and feet on stainless-steel electrodes. The method uses low voltage to stimulate the sweat glands and measure the electrochemical reaction between electrodes and chloride ions. This active, new method provides information and evidence of a sweat dysfunction that might otherwise not be detectable in physiological conditions. Bioelectrical Conductances (BEC, in micro siemens, uS) for the hands and feet express the quantitative results, while a risk score derives from demographic data and the BEC values.

The VitalScan SudoCheck system, in accordance with the 21 CFR 882.1540, represents a sympathetic skin response device that provides skin conductance measurements on a computer screen.

VitalScan SudoCheck is, similar to a galvanic skin response stress test, a functional test that measures the sweat glands' capacity to release chloride ions following an electrochemical stimulation. It works by measuring the electrical potential difference caused by the electrochemical reaction of electrodes, which are applied to the skin and stimulated by a low voltage of variable amplitude. VitalScan SudoCheck comes with 4x2 independent electrodes for placement on feet or palms and other areas with a high number of sweat glands.

VitalScan SudoCheck provides information that determines the cardiometabolic risk in patients.

Analytical Overview


  • Small unmyelinated C-fibers are responsible for the function of sweat glands
  • Sudomotor dysfunction has been established as one of the earliest detectable neurophysiologic abnormalities in distal small fiber neuropathies.
  • A quantitative assessment of sweat response is an index of the severity and distribution of automatic failure. It will also serve as an early indicator for the regeneration of small fibers.
  • Diabetic patients have been observed to experience a degeneration of small C-fiber innervating sweat glands.
  • Measures bio electrochemical sweat skin conductances (BEC) are directly connected to the capability of the glands to transfer chloride ions and which reflects small-C fiber status.
  • VitalScan SudoCheck is a fast and easy method to measure sweat function
  • 3 minutes or 6 minutes test options.

Advantages


  • It does not require any patient preparation, such as blood drawing or fasting.
  • Non-invasive and delivers immediate results, with findings within 3 minutes.
  • It was developed for general practitioners, cardiologists, and neurologists to assist in the effective screening of cardiometabolic risk in patients.
  • Evaluate patients with Diabetes Mellitus, as an instrument to assess autonomic neuropathy and neuropathic pain.
  • Operates with a sensitivity of 80% and a specificity of 95%.
  • Results suggest that the peripheral autonomic nervous system plays a role in painful diabetic neuropathy.
  • Results correlated significantly with clinical neuropathy scores, pain scores and measures of autonomic dysfunction.
  • Evaluate in patients with Diabetes Mellitusm, as an instrument to assess autonomic neuropathy and neuropathic pain.
  • VitalScan SudoCheck is an innovative, sensitive tool for the detection of diabetic neuropathy, especially painful diabetic neuropathy. As sweat glands are innervated by small c fibers, which are also involved in pain pathways, precise measuring of the sweat gland function can identify that cause.

Evaluation Of Sudomotor Function


Why evaluate sudomotor function?
The study of sudomotor presents a valuable tool to assess autonomic disorders. Sudomotor function is known to reflect sympathetic activity and provide insight into postganglionic autonomic innervation.
Recent clinical studies have shown that the level of glycemia influenced conventional tests. VitalScan SudoCheck, however, has proven to be a reproducible and quantitative test method. In addition, VitalScan SudoCheck's Bio Electrochemical Sweat Conductance (BEC) reflects sympathetic dependent sweat function.

The need for a faster sudomotor function test
Sudomotor function assessment can now be carried out faster and simpler with the new VitalScan SudoCheck technology.
In response to electrochemical activation, it measures the ability of sweat glands to release chloride ions and detects abnormalities. Once suspected or confirmed, more specialized tests are recommended to diagnose the underlying cause of the irregularity.
Evaluation of sudomotor function in diabetes
On of the significant causes of nerve damage is diabetes. Diabetic patients suffer from metabolic impairment and related inflammatory processes. As a result, their non-myelinated axons of small fiber nerves are primarily affected and known as Diabetic Autonomic Neuropathy (DAN).
There are presently several clinical studies ongoing to validate VitalScan SudoCheck's new technology for DAN detection.

Small fiber nerves are early victims of diabetes
While symptoms remain sub-clinical, diabetes affects the peripheral nervous system, and small nerve fibers are usually the first victims. VitalScan SudoCheck was developed as a new device to follow up on complications related to diabetes.


Left side - Normal innervation of a sweat gland at the distal leg in a healthy person.
Right side - Reduced innervation of a sweat gland in a diabetic patient.
The VitalScan SudoCheck system is a Class II medical device that is US FDA 510(K) cleared.

VitalScan SudoCheck testing procedure is covered by the most major insurance providers, under CPT code 95923.

Designed for Clinicians, by Clinicians