Rapid Response Device Assesses Head Trauma Patients

A noninvasive, handheld system uses an in situ electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain after head injury.

The BrainScope Ahead 100 utilizes product miniaturization and advanced signal processing methods to provide an objective assessment and categorization of brain electrical activity associated with brain injury, identifying patterns consistent with a traumatically induced structural brain injury and clinical manifestations of functional traumatic brain injury (TBI). It is indicated for use as an adjunct to standard clinical practice for evaluation of patients who sustained a closed head injury within 24 hours, between the ages of 18–80 years, and who are being considered for a head computerized tomography (CT) scan.

The system consists of three main components: a hand-held device that includes software and algorithms for EEG acquisition, analysis, and patient stratification; a disposable electrode headset; and a web-based capability for centralized storage and review of patient data. The application of advanced mathematics and miniaturized hardware is designed to bridge the limitations of traditional EEG and provide tools for an initial assessment and adjunctive assessment across the brain care path. The Ahead 100 is a product of BrainScope (Bethesda, MD, USA), and has been approved by the US Food and Drug Administration (FDA).

“Over the last two years, we have focused on improving this technology, including adapting it for use on ubiquitous hardware platforms such as smartphones and tablets, and by benefitting from machine learning and proprietary algorithm classification techniques from increased data derived from our numerous clinical studies,” said Michael Singer, president and CEO of BrainScope. “We will direct all of our commercialization efforts for the Ahead product family using these hardware platforms both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field.”

“Using sophisticated classification algorithm methods we sought neurophysiological profiles or signatures of changes in brain electrical activity associated with traumatic structural brain injury,” said Leslie Prichep, MD, director of the quantitative neurophysiological brain research lab at the NYU School of Medicine (NY, USA), and consultant to BrainScope. “One of the most important findings was the extremely high performance of the Ahead 100 to identify the absence of structural brain injury after a patient has sustained a head injury. This provides important information to the clinician, contributing to a rule-out for one of the most prevalent concerns clinicians have with mildly presenting patients.”

Head injury is the leading cause of death and disability in people under 45 years of age in developed countries, mostly resulting from falls and road accidents. The primary injury is caused by an initial mechanical force, followed by a secondary injury which develops in the hours and days afterwards, which is largely responsible for patients' mental and physical disabilities.

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