BrainScope Company, Inc. today announced its sponsorship of a multi-center, observational clinical study, the "B-Ahead U.K. Trial", utilizing its technology in development to aid in the assessment of traumatic brain injury (TBI) and its milder forms (commonly referred to as "concussion") in emergency departments in the United Kingdom.
Dr. Rupert Pearse, M.D. from Barts and The London School of Medicine and Dentistry will serve as chief investigator for the study, which is expected to commence in late spring 2011. Dr. Pearse is based at the distinguished Royal London Hospital, a center of excellence in the U.K. which treats more trauma patients than any other center in the U.K. Salford Royal Hospital, based in the Manchester, England area, has also formally committed to participate in the study, and BrainScope is currently in discussions with other leading centers within the U.K. This U.K. trial is the first clinical study for BrainScope outside of the United States.
"I am enthusiastic about the potential for this novel medical technology from BrainScope and delighted to be involved in this important research on head injury in the U.K.," said Dr. Pearse. "The prospect of having a noninvasive, handheld, point of care, objective medical device to help evaluate head injury patients seen in the emergency department could greatly assist clinicians in triage, assessment and management of these patients."
The B-Ahead U.K. Trial will study patients in the emergency department (commonly known as the accident & emergency department, or "A&E") with a suspected head injury. Patients will receive standard clinical assessment and treatment during the course of the study. BrainScope's Ahead™ medical device in development will be used to collect, process and produce an assessment of the patients' brain electrical activity, identifying patterns consistent with a traumatically-induced structural brain injury and/or clinical manifestations of functional brain injury. The study was recently adopted by the U.K. National Institute for Health Research (NIHR) Clinical Research Network Portfolio, which provides research credibility and facilitates collaboration at the local research network level.
"We are excited about the opportunity to sponsor this multi-center study in the U.K. and honored to collaborate with these prestigious institutions and thought leaders," said Michael Singer, CEO of BrainScope. "Traumatic brain injury knows no boundaries, and we are very interested in the European market, beginning with the United Kingdom."
According to Headway - the brain injury association, "Each year an estimated 1 million people attend hospital A&E in the U.K. following head injury. Many more head injuries go unreported and are not assessed by medical professionals."
Currently, BrainScope is sponsoring clinical data collection in TBI-focused research protocols for algorithm development with leading universities and hospitals in the U.S. 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 School of Medicine (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 marketing review.
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