BrainScope announced its sponsorship of the B-Ahead UK trial, a multicentre, observational clinical study, with the provision of its technology in development to aid in the assessment of traumatic brain injury and its milder forms in emergency departments in the United Kingdom.
The B-Ahead UK 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, which is expected to commence in late spring 2011, was recently adopted by the UK National Institute for Health Research (NIHR) Clinical Research Network Portfolio.
Rupert Pearse, from Barts and the London School of Medicine and Dentistry and chief investigator for the study commented, “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.”
Pearse is based at the Royal London Hospital, UK, which treats more trauma patients than any other centre in the UK. Salford Royal Hospital, Manchester, UK, has also formally committed to participate in the study. BrainScope is currently in discussions with other leading centres within the UK.
“We are excited about the opportunity to sponsor this multicentre study in the UK and honored to collaborate with these prestigious institutions and thought leaders,” said Michael Singer, CEO of BrainScope.
According to Headway – the brain injury association, “Each year an estimated 1 million people attend hospital A&E in the UK following head injury. Many more head injuries go unreported and are not assessed by medical professionals.”
BrainScope is currently sponsoring clinical data collection in TBI-focused research protocols for algorithm development with leading universities and hospitals in the USA including Brooke Army Medical Centre 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 Centre in Charlottesville, Virginia; University of Maryland School of Medicine (R Adams Cowley Shock Trauma Centre) 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.