Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope Ahead® Technology (B-AHEAD II Trial)

Principal Investigators

Dr. Jeffrey J. Bazarian


Introduction

Emergency departments are required to see a large number of patients with a minor/mild head injury, and identify the very small number of these that will go on to have serious complications. The challenge to the emergency medicine clinician is identifying which patients with a head injury have an important brain injury that requires further attention and which patients can be safely sent home. The standard for determining an important brain injury is the result on the Computerized Tomography (CT) scan of the head. CT scanning is non-portable, costly, time-consuming, and exposes individuals to high radiation levels. BrainScope’s Ahead® M-100 is being developed to address the unmet need for a medical device to aid in triage of patients who are suspected of traumatic brain injury (TBI). It will provide objective and timely adjunctive assessment of structural brain injury and functional impairment from TBI.

Purpose

To assess the severity of head injury by developing a portable point of care system based on objective electrophysiological data on brain function; to asses medical professionals in making informed decisions for triage, treatment, and care.

Design Methods

This is a multisite, prospective, non-randomized trial for the validation of the BrainScope Ahead® M-100 in support of an FDA marketing application. Patients suspected of a traumatically induced brain injury and non-head injured controls will undergo standard clinical assessments, neurocognitive evaluation, and electrophysiological assessment with the Ahead® M-100.

Significance of the Study

BrainScope Company, Inc. (Bethesda, MD) is developing a new generation of portable, simple-to-use, noninvasive instruments to aid medical professionals in rapidly and objectively providing clinically meaningful information to aid in the assessment of brain function at the initial point of care. The Ahead® M-100 is a handheld, non-invasive, non-radiation emitting medical device in development that could provide a rapid and objective assessment and categorization of brain injury, based on patterns identified in brain electrical activity. The Ahead® M-100 could be utilized as an adjunct to standard clinical practice assessment in the United States Military Health System to aid in the triage of injured military personnel, as well as to assist emergency medicine clinicians in early identification, staging, and optimization of treatment for patients who are head injured.