VITAL Study Demonstrates Stroke Severity Detection Capabilities of Cerebrotech’s Noninvasive VIPS Technology
July 26, 2017–Cerebrotech Medical Systems, Inc. announced findings from the VITAL study evaluating the company’s Volumetric Integral Phase-shift Spectroscopy (VIPS) technology for emergency stroke patients. Christopher P. Kellner, MD, presented the data at the 14th annual meeting of the Society of NeuroInterventional Surgery in Colorado Springs, Colorado.
In the multicenter VITAL study (N = 128), a noninvasive, visor-like neurological device demonstrated the ability to distinguish between severe strokes (both ischemic and hemorrhagic) and smaller strokes, allowing for earlier intervention to prevent further brain damage. "This device has the potential to dramatically improve our stroke systems of care," stated Dr. Kellner in his presentation.
VIPS passes low-energy electromagnetic waves through the brain, detecting small changes to its electrical properties, described Cerebrotech. These electrical characteristics, called bioimpedance, are related to brain tissue and fluid status, and asymmetries can be indicative of clinical problems. The device has received European CE Mark approval, though it is not yet cleared for sale in the United States.
Dr. Kellner reported that the VIPS device is capable of differentiating large strokes from small strokes with a sensitivity of 93% (95% confidence interval [CI], 83–98) and a specificity of 92% (95% CI, 75–99). A comparison of large strokes to healthy adults yielded 100% specificity. The acquisition time using the device is less than 30 seconds.
The company noted that Dr. Kellner’s presentation also demonstrated the underlying reasons why the device offers this level of accuracy. The data show that patients with large strokes (55 ischemic and two hemorrhagic) have substantially 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 patients had an average asymmetry score of 16.5% (CI, 14.6–18.4) versus those with small strokes, who had an average asymmetry score of 8% (95% CI, 6.9–9; P < .0001). Average bioimpedance asymmetry in a cohort of 79 healthy adults was 5% (95% CI, 4.5–5.5). By measuring bioimpedance asymmetry, the device is able to identify stroke and differentiate large strokes from small strokes.
“This multicenter clinical trial shows the viability of a noninvasive technology that can quickly identify treatable devastating strokes in ambulances or emergency rooms, and rapidly triage those patients to special treatment centers—saving lives," commented Dr. Kellner in the company’s announcement. "This trial demonstrates that Cerebrotech’s device has the potential to do for stroke what electrocardiogram has done for heart attack.”
Dr. Kellner is Director of the Mount Sinai Intracerebral Hemorrhage Center and Assistant Professor of Neurosurgery, Icahn School of Medicine at Mount Sinai Hospital in New York, New York.