Volumetric Integral Phase-shift Spectroscopy (VIPS), a noninvasive, visor-like device developed by Cerebrotech Medical Systems, demonstrated the ability to differentiate large strokes from small strokes in ambulances or emergency departments, the VITAL study suggests.
The device is designed to pass low-energy electromagnetic waves through the brain and detect small changes to the brain’s electrical properties. These characteristics, called bioimpedance, are related to brain tissue and fluid status, and asymmetries can be indicative of clinical problems, according to a media release from Cerebrotech Medical Systems.
“This multi-center clinical trial shows the viability of a non-invasive technology that can quickly identify treatable devastating strokes in ambulances or emergency rooms to enable rapid triage those patients to specialized, capable treatment centers, thereby saving lives,” says Christopher P. Kellner, MD, director of the Intracerebral Hemorrhage Program at Mount Sinai and Assistant Professor of Neurosurgery at the Icahn School of Medicine at Mount Sinai, in the release.
Kellner presented data from the VITAL study—conducted to evaluate patients presenting with a range of brain injuries, including strokes—recently at the 14th Annual Meeting of The Society of NeuroInterventional Surgery in Colorado Springs, Colo.
Researchers from Icahn School of Medicine at Mount Sinai (New York City), The Medical University of South Carolina, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, and Baptist Medical Center Jacksonville participated in the study. A study of healthy volunteers was also conducted for baseline comparison.
According to the data from the study, the VIPS device is capable of differentiating large strokes from small strokes with sensitivity of 93% (95% CI 83-98) and specificity of 92% (95% CI 75-99). Comparison of large strokes to healthy adults yielded 100% specificity, the release explains.
The data also provided reasons for this accuracy, the release continues: Subjects with large strokes (55 ischemic and 2 hemorrhagic) have significantly higher bioimpedance asymmetry, a measure of the electrical characteristics of the brain, compared to those with small strokes (16 ischemic and 10 hemorrhagic) that do not require emergent triage to special centers. Large stroke subjects had an average asymmetry score of 16.5% (95% CI 14.6-18.4), versus those with small strokes, which had an average asymmetry score of 8.0% (95% CI 6.9-9.0, p<0.0001). Average bioimpedance asymmetry in a cohort of 79 healthy adults was 5.0% (95% CI 4.5-5.5). By measuring bioimpedance asymmetry, the device is able to identify stroke and differentiate large strokes from small strokes.
“There is a critical, highly visible unmet need for effective, early stroke assessment in ambulances and emergency rooms to identify which patients need triage directly to specialty stroke hospitals for immediate surgical intervention,” states Mitch Levinson, president and CEO, Cerebrotech Medical Systems, in the release.
“By helping to minimize treatment delays, this technology has the potential to substantially improve healthcare outcomes for hundreds of thousands of people each year across the globe.”
[Source(s): Cerebrotech Medical Systems, PR Newswire]