A study of 183 patients published in the journal Academic Emergency Medicine found that an investigational, non-radiation-emitting, hand-held device developed by BrainScope is a valuable adjunct to standard CT and MRI scans in the diagnosis of stroke.
The device gathered 10 minutes of electroencephalographic data from 5 frontal electrodes, and identified acute stroke patients 92% of the time. In addition to the 48 stroke patients, there were 135 stroke mimic controls in the study. The device had a specificity to the mimics of 50.4%, meaning that it correctly concluded that the patient was not having a stroke half of the time.
"Despite a small population and the use of a classification algorithm derived without the benefit of 'training' it on a population of stroke and stroke mimic patients, this data suggests the potential clinical utility of this technology as an adjunct to acute assessment of stroke," said Dr. Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories and professor of psychiatry at the New York University School of Medicine in a BrainScope release touting the findings.
Prichep's labs participated in the study, along with the emergency medicine department of University Hospitals Case Medical Center in Cleveland and the Johns Hopkins University School of Medicine's division of brain injury outcomes.
Crucially, 80% of the stroke patients who tested negative for stroke using a CT scan, but were later correctly diagnosed after receiving an MRI, were properly diagnosed as having a stroke by the investigational device. BrainScope said that this finding suggests the device could help doctors allocate resources efficiently, and reduce unnecessary radiation exposure.
The study abstract concludes: "(D)espite a small population and the use of a classifier without the benefit of training on a stroke population, these data suggest that a rapidly acquired, easy-to-use system to assess brain electrical activity at the time of evaluation of acute stroke could be a valuable adjunct to current clinical practice."
In November 2014, the FDA cleared BrainScope's Ahead 100 wearable device to provide an electroencephalograph that is analyzed to assess the structural condition of a patient's brain after head injury. The first-line diagnostic device for TBI is typically a CT scan.
"While we as a company have fully focused our development efforts on Traumatic Brain Injury and concussion, this peer-reviewed publication provides initial compelling evidence about the potential for our overall technology platform to assess the existence of stroke shortly after it occurs," BrainScope CEO Michael Singer said in a statement. "We are highly encouraged by the results of this study and will continue to look for opportunities to expand our capabilities in stroke, which is of course a substantial worldwide clinical need."
- read the release
- here's the study abstract