EEG-based Brain Function Index for Head Injury Assessment Passes Validation Trial

BrainScope Company releases a publication describing that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.


Published online in the peer-reviewed Journal of Neurotrauma in an article entitled “A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial”, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients. These trial results were presented to the U.S. Food and Drug Administration (FDA) in support of endpoints, leading to FDA’s clearance in September 2016 to market BrainScope One (registered as Ahead 300).


The lead author of the study is Daniel Hanley Jr., M.D., the Jeffrey and Harriet Legum Professor of Acute Care Neurological Medicine and Director of the Brain Injury Outcomes Program at the Johns Hopkins University School of Medicine. Hanley noted, “This is a truly exciting discovery, as it opens up the door to quantitative assessment of concussion.”


Importantly, the BFI was derived using features of brain electrical activity associated with functional brain impairment reflecting current consensus on the physiology of concussive injury. In the study, mildly presenting adult patients were evaluated within three days of sustaining a closed head injury. Standard clinical evaluations were conducted, and 5-10 minutes of EEG were acquired from locations on the forehead. The study demonstrated that the mild functionally impaired group and the moderate functionally impaired group, both as compared to uninjured, were significantly different from the CT+ (structural injury visible on CT) TBI group (p=0.0009 and p=0.0026, respectively).


BrainScope One is an FDA-cleared medical device for rapid, objective assessment of mildly presenting adult head injured patients across the full spectrum of brain injury at the point of care for up to three days following injury, and is designed to help the clinician address not only whether a patient has a functional brain injury, including concussion, but also whether a patient has structural brain injury visible on CT.


To aid in interpretability for assessment of brain injury, BrainScope One resultsinclude the EEG-based BFI expressed as a percentile of an age-regressed, non-head injured population. The head injured BFI percentile score is also displayed relative to the significance of the distance from the mean of the non-head injured population, categorized as “average”, “below average” (1.5 standard deviations from the mean) or “clearly below average” (2 standard deviations from the mean).


In addition to the BFI, BrainScope One addresses structural brain injury with its Structural Injury Classifier (SIC), based on the same EEG, indicating whether a head injured patient is likely CT+, CT- or Equivocal. The SIC results of BrainScope’s FDA validation trial were published in the peer-reviewed journal Academic Emergency Medicine earlier this year, showing 99% sensitivity to the presence of the smallest amount of detectable blood on an independent read of the CT scan (≥1cc), with negative predictive value (NPV) of 98%.


“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,” stated Michael Singer, BrainScope’s Chief Executive Officer.


This is the 21st peer-reviewed publication supporting BrainScope’s technology. The full citation for this article is: Hanley D, Prichep L, Badjatia N, Bazarian J, Chiacchierini R, Curley K, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright D, and Huff JS. A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial. Journal of Neurotrauma. June 2017, ahead of print.


The full citation for the previously published article relating to structural brain injury assessment (CT+/CT-) is: Hanley D, Prichep L, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones E, Wright D, O'Neill J, Badjatia N, Gandhi D, Curley K, Chiacchierini R, O'Neil B, Hack D. Emergency Department triage of traumatic head injury using brain electrical activity biomarkers: a multisite prospective observational validation trial. Academic Emergency Medicine 2017; doi:10.1111/acem.13175.


BrainScope One is available to a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, hospital Emergency Departments, university and professional sports, and the U.S. military and government.


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