The results of the VITAL study demonstrate that a non-invasive, visor-like neurological device (VIPS technology from Cerebrotech Medical Systems) can identify those patients with large vessel occlusion (LVO) strokes and large haemorrhagic strokes versus those with less urgent strokes, allowing for earlier intervention to prevent further brain damage.
The VITAL study was presented at the Society of NeuroInterventional Surgery’s annual meeting (SNIS; 24–28 July, Colorado Springs, USA).
“This multicentre 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 specialised, capable treatment centres, thereby saving lives. This trial demonstrates that Cerebrotech’s device has the potential to do for stroke what EKG has done for heart attack,” said Christopher P Kellner, director of the Intracerebral Hemorrhage Program at Mount Sinai and assistant professor of Neurosurgery at the Icahn School of Medicine at Mount Sinai, New York, USA.
Kellner presented data demonstrating that the VIPS technology 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.
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 ischaemic and 2 haemorrhagic) have significantly higher bioimpedance asymmetry, a measure of the electrical characteristics of the brain, compared to those with small strokes (16 ischaemic and 10 haemorrhagic) that do not require emergent triage to special centres. Large stroke patients 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% (95%, CI 6.9–9.0, p<0.0001). 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.
The presented data consisted of: the VITAL study (n=128), which evaluated patients presenting with a range of brain injuries including strokes and was conducted by a group that included distinguished researchers from Icahn School of Medicine at Mount Sinai, the Medical University of South Carolina, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, and Baptist Medical Center Jacksonville; an initial pilot study (n=41) conducted at the Medical University of South Carolina; and a study of healthy volunteers for baseline comparators.
The VIPS (volumetric integral phase-shift spectroscopy) technology, passes low-energy electromagnetic waves through the brain, detecting small changes to the brain’s electrical properties. These electrical characteristics, called bioimpedance, are related to brain tissue and fluid status, and asymmetries can be indicative of clinical problems. Quantitative results provided by the device can be obtained in seconds by medical professionals after minimal training, and the simple device design allows results to be obtained without interfering with any aspect of patient care. The device holds a CE mark, but is not yet cleared for sale in the USA.