BrainScope Company, Inc. today announced the publication of clinical research findings from a study in patients presenting to the Emergency Department (ED) following a closed head injury. The study published in the peer-reviewed journal Brain Injury, the official journal of the International Brain Injury Association, entitled "Use of brain electrical activity to quantify traumatic brain injury in the emergency department", suggests BrainScope's technology, compared with Computed Tomography (CT), may provide clinically useful triage for CT in patients presenting to the ED.
"This study suggests that clinical presentation alone may not be sufficient to make a prediction regarding the presence of abnormal brain function," said Dr. Rosanne S. Naunheim, MD, Associate Professor of Emergency Medicine, Washington University School of Medicine in St. Louis who was the lead author of the study. "Having completed this study, there is great promise that this portable technology will be able to predict which patients are abnormal after a closed head injury. We found the device easy to use and predictive of whether CT scans were positive or negative which could be exceptionally useful in triaging patients, whether on the sidelines in sports, the battlefield or the urban Emergency Department."
The purpose of the study was to determine the feasibility of BrainScope's technology to distinguish between patients who present with mild head injury symptoms, but result in either a positive head CT scan (CT+) (a head injury severe enough to warrant more extensive evaluation and treatment), a negative head CT scan (CT-), and ED control (normal) patients. The study, led by Dr. Naunheim, was conducted in collaboration with Washington University's Barnes Jewish Hospital and New York University's Bellevue Hospital Center. The study, conducted with written informed consent, enrolled 105 head injury patients (53 CT+ and 52 CT-) with complaints of altered mental status following a closed head injury and 50 ED controls patients. The majority of patients were enrolled within 24 hours of the suspected injury and involved a variety of mechanisms for injury, including assaults, falls, motor vehicle, pedestrian and sport-related accidents. The BrainScope device was used to assess the degree of abnormality in brain function as measured by brain electrical activity.
The findings of the independent study indicate that despite no significant differences between reported clinical symptoms in the CT+ and CT- groups, the BrainScope technology demonstrated high sensitivity (92.4%) and specificity (90.0%) in identifying the CT+ group, those patients who needed immediate imaging.
"The publication of this study is a major milestone in our efforts to develop a useful medical device for quickly assessing clinically important traumatically induced head injuries in an emergency care setting. There is now a growing body of literature supporting the potential of brain electrical activity to be highly sensitive in assessing patients with both severe, structural brain injury and milder forms of brain injury, such as those resulting from sport and military related injuries," said Michael Singer, CEO of BrainScope.
The full study can be found at http://informahealthcare.com/doi/abs/10.3109/02699052.2010.506862.
Additional studies to replicate and further investigate the potential clinical utility of BrainScope's technology in the ED are currently underway. BrainScope's novel technology under development aims to address traditional technology constraints through the use of portable point-of-care products that employ a disposable compact frontal electrode headset for data collection, miniaturized hardware, and advanced algorithms that quantify and characterize features of brain electrical activity, such as those associated with TBI.
Currently BrainScope is undergoing additional clinical data collection of TBI-focused research protocols for algorithm development with leading universities and hospitals in the United States including Brooke Army Medical Center in Fort Sam Houston, Texas; Washington University in St. Louis, Missouri (Barnes Jewish Hospital); William Beaumont Hospitals in Royal Oak and Troy, Michigan; Wayne State University (Detroit Receiving Hospital and Sinai Grace Hospital) in Detroit, Michigan; University of Virginia Medical Center in Charlottesville, Virginia; University of Maryland (R Adams Cowley Shock Trauma Center) in Baltimore, Maryland; and Waukesha Memorial Hospital in Waukesha, Wisconsin. BrainScope devices under development for assessment of traumatically-induced head injury and concussions are for investigational use only and have not been submitted for FDA review.
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