The publication of an independent, prospective validation study has demonstrated the potential clinical utility of the BrainScope technology for the identification of acute traumatic intracranial haematomas in patients who present to hospital emergency departments.
The results of the study, “Identification of hematomas in mild traumatic brain injury using an index of quantitative brain electrical activity”, appeared online ahead of print in the Journal of Neurotrauma, authored by investigators from New York University School of Medicine and The Johns Hopkins University School of Medicine, USA.
The technology records brain electrical activity with a handheld, rapid, easy-to-use, non-invasive and non-radiation emitting device, according to BrainScope. The technology utilises advanced signal processing methods and classification algorithms that quantify and characterise features of brain electrical activity associated with traumatic brain injury.
In this prospective validation study, ten minutes of brain electrical activity were recorded in 46 adult patients with traumatic haematomas with measureable blood (CT scan positive, ≥1cc of blood) and 278 head-injured control patients (CT scan negative). The mild presentation of the entire study population is reflected by 97% (313/324) of the patients in the study having a normal Glasgow Coma Scale score of 15 (on a scale of 3–15), with a mean value of 14.7 for the population with haematomas, and 14.9 for the control group. The volume of blood and distance from recording electrodes were measured by blinded independent experts. A previously derived classification algorithm developed by BrainScope (the “TBI-index”) was used to identify the probability of a traumatic CT positive lesion in this clinically important independent population.
The study reported a sensitivity of 96% to haematomas, which was independent of type of haematoma, blood volume, or distance of the bleed from the recording electrodes on the forehead. Because of the life-threatening risk associated with undetected haematomas, specificity was permitted to be lower (44%) in exchange for extremely high sensitivity. In this study population (n=324), all subjects had been referred for CT scanning by standard clinical practice, of whom 278 were found to be CT negative. These results replicate previously peer-reviewed published findings (Hanley and colleagues, Journal of Neurotrauma, 2013) using the technology in traumatic haematomas, and again importantly demonstrated that the distance and volume restrictions noted with other commercially available methods for detecting traumatic intracranial haematomas were not limitations of BrainScope’s technology. These results lend further strong support to the potential enhanced clinical utility of the BrainScope TBI-Index as an important adjunct to acute assessment and triage of clinically important (potentially life-threatening) brain injuries.
“Often patients such as those in this study present with very mild symptoms of traumatic brain injury and therefore pose difficult triage decisions upon clinical evaluation. It is not always clear whether the patient might have a clinically important traumatic brain injury (blood in the brain) requiring further clinical evaluation. The ability to determine the likelihood of presence of such injuries non-invasively and without radiation could result in a paradigm shift in the way emergency medicine for TBI is currently practiced,” says Michael Singer, president and chief executive officer of BrainScope. “This peer-reviewed publication, which independently validated the prior 2013 publication, provides further compelling evidence about the potential for our technology to help assess the existence of brain injuries shortly after injury. Whether in the military or civilian hospital emergency departments, there is a true need for an objective, adjunctive assessment tool for TBI beyond what currently exists. We are highly encouraged by the independent prospective replication of these results.”
BrainScope devices under development for assessment of traumatically-induced head injury and concussion are for investigational use only.