BrainScope today touted results from a study of its EEG-based Brain Function Index, part of its BrainScope One device, which demonstrated a “significant relationship” between BFI readings and the severity of functional impairment in mild head injuries.
The study was published in the Journal of Neurotrama this month, the Bethesda, Md.-based company said.
The company’s BrainScope One is an FDA-cleared device designed for assessing mildly presenting adult head injuries across the full spectrum of injuries for up to 3 days following the injury, the company said.
The system is designed to help clinicians assess functional brain injuries and determine whether patients have structural brain injuries visible on CT scans.
Data from the 720-patient trial supported BFI as a quantitative biomarker of brain function impairment, BrainScope said, which scales with the severity of the impairment in patients with mild brain injuries.
“This is a truly exciting discovery, as it opens up the door to quantitative assessment of concussion,” study lead author Dr. Daniel Hanley Jr. of Johns Hopkins University School of Medicine said in a prepared release.
BrainScope said that BFI in the trial was derived using features of brain electrical activity associated with functional brain impairment which reflects the current consensus on the physiology of concussive injury. Patients in the trial were evaluated within 3 days of head injury, with both standard evaluations and 5-10 minutes of EEG.
Results from the trial indicated that mild functionally impaired and moderate functionally impaired groups showed significant differences from patients who had structural injury visible on CT scans.
“This important study clearly indicates that when integrated into clinical assessment, the BFI provides an objective physiological biomarker to aid in the early diagnosis of functional brain injury, and thereby has potential to impact the sequelae of brain injury,” chief scientific officer Dr. Leslie Prichep said in a prepared statement.
“The results of our FDA validation trial, now expressed in two pivotal publications, clearly show the benefit of both the Brain Function Index and the Structural Injury Classifier as objective, EEG-based physiological biomarkers for assessment of the full spectrum of brain injury, from functional to structural injury, available at the point of care on a handheld medical device,” CEO Michael Singer said in a press release.
