The first AI‐enabled, point-of-care test for the rapid diagnosis and prognosis of mild Traumatic Brain Injury (TBI) has shown positive test results.
BRAINBox TBI is a multi-modal test that combines clinical data, neurocognitive testing, symptom reporting and blood-based biomarkers in combination with AI algorithms to generate an objective score for diagnosis up to 96 hours from the time of injury.
A prognosis report is also generated by the test, providing information on the likelihood of injury-related symptoms occurring at 30 days and up to three months after the event.
BRAINBox Solutions, which has developed the test, has confirmed that enrolment in its HeadSMART II trial – a multi-national, multi-site trial, in adult subjects designed to support an application for regulatory clearance by the U.S. FDA – has been expanded to meet FDA requirements for study population diversity.
The paediatric pilot study has been completed and planning has now begun for a pivotal trial in the 10 to 18-year-old population, where sports injuries put the youth population at risk.
Additionally, the geriatric trial is evaluating a refinement of the TBI test equilibrated for the elderly population and is designed to enable rapid concussion diagnosis and prognosis at the bedside with a single device.
To date, 200 geriatric patients with suspected concussion have been enrolled in the trial.
“Acute traumatic encephalopathy is a major clinical issue that cuts across age groups and the injuries that occur in many different settings,” said Dr. Frank Peacock, lead investigator in the HeadSMARTII trial and a member of BRAINBox’s scientific advisory board.
“The data to date from these studies in presentations over the past several months and upcoming publications highlight the breadth of clinical data and the clear evidence of the continued symptoms that result from the lack of a clear diagnosis and early intervention.
“The tests are designed to fill a pressing need for an objective assessment to diagnose concussions and determine a patient’s prognosis at the time of injury no matter where the injury occurs.”
He added that the studies to date underscore diagnostic and prognostic value and the necessity of combining blood biomarkers with cognitive testing, with a panel of three blood biomarkers enhancing the specificity of cognitive tests.
Donna Edmonds, BRAINBox Solutions CEO, said: “We are very encouraged by the preliminary data from our collaborations to enable the blood biomarker component of the test to go on a point-of-care instrument so it can be used in any clinical setting.
“The ability to assess biomarkers at the point of care is key to use of the test in outpatient as well as emergency department settings.”
