April 3, 2018 Source: Health Data Management 127
A new visor-like device worn by patients can help providers and emergency medical personnel detect a stroke that requires comprehensive care within seconds and with greater than 90 percent accuracy.
The volumetric impedance phase shift spectroscopy (VIPS) device, made by neurotechnology vendor Cerebrotech Medical Systems, identifies patients having a stroke by sending low-energy radio waves through the brain that assess fluid volume differences (asymmetry) between the cerebral hemispheres—which are indicative of a stroke.
The radio waves change frequency when passing through fluids and are reflected back through the brain, with small changes and asymmetries in electrical properties detected by the VIPS device.
Time is of the essence in diagnosing stroke patients and properly treating them, given that the chance of achieving a good outcome decreases by about 20 percent for each hour that passes before treatment.
Clinical investigators conducted a study, funded by Cerebrotech Medical Systems, in which healthy participants and patients with suspected stroke were both evaluated by emergency medical personnel using the device. The neurologic assessment included taking three scans of the brain that took just 30 seconds to complete. In addition, patients were later evaluated by neurologists who provided definitive diagnoses using neuroimaging.
“The VIPS device is a portable, non-invasive and easy to use tool that may aid in the detection of severe stroke, including emergent large vessel occlusion (ELVO), with a sensitivity of 93 percent and specificity of 92 percent in this derivation study,” conclude the authors, who published the results this month in the Journal of NeuroInterventional Surgery.
By comparison, a standard physical examination achieved only 40 percent to 89 percent accuracy in identifying patients with ELVO, according to the study.
“Very quickly, very easily—without exposing the patient to the radiation of a CAT scan—we can figure out what is a stroke and what is not a stroke,” says Raymond Turner, MD, a principal investigator for the study, professor of neurosurgery and chief of the Neuroscience Integrated Center of Clinical Excellence at the Medical University of South Carolina.
Turner notes that the VIPS device is now approved by the Food and Drug Administration—it received clearance from the regulatory agency a few months ago, he reports. “When we were actually doing this study, it was not FDA-approved.”
Cerebrotech Medical Systems, which developed a proprietary machine learning system to optimize its algorithms to recognize and differentiate between the bioimpedance profiles of various brain pathologies, is continuing its clinical studies to further validate the device.
In the second phase of the Non-Invasive Detection of Hemispheric Bioimpedance Asymmetry in Severe Brain Pathology study, Turner says that investigators will seek to determine if the VIPS device can use complex machine learning algorithms to teach itself how to discriminate between minor and severe stroke without the help of neurologists.
“This is really exciting technology,” concludes Turner. “We want to explore whether or not we can detect an ischemic stroke from a hemorrhagic stroke. There are a couple of things that we’re still trying to play around with to see if we can get it even more accurate in the diagnosis.”
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