Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
The purpose of the current study is proposed to prospectively assess how accurately the
 BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.
One million patients attend Emergency Departments (ED) with head injuries each year in the
 United Kingdom (UK) and Ireland. 150,000 of these patients will need hospital admission and
 one study estimates an incidence of 45-48% moderate or severe disability in those surviving
 admission. Although the incidence of head injury is high, the incidence of death from head
 injury is low. Therefore ED's 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 Computerised Tomography (CT) scan of the head. CT scanning is
 nonportable and exposes individuals to high radiation levels.

 The study medical device is a portable, point of care, noninvasive and non radiation-emitting
 medical device designed to assist clinicians in early identification, staging, and
 optimisation of treatment for patients who are head injured.
Inclusion Criteria:

 -  Males and females ages 18 to 80 (the entire age range), who are admitted to the
 Emergency Department (ED), who are suspected of a traumatically induced structural
 brain injury and/or clinical manifestations of functional brain injury, as a result of
 insult to the head from an external force, e.g., the head being struck by an object,
 the head striking an object, the head being exposed to forces generated from a blast
 or explosion, and/or the brain undergoing an acceleration/deceleration movement
 without direct external trauma to the head with a Glasgow Coma Scale of >8. The acute,
 suspected traumatically induced structural brain injury and/or clinical manifestations
 of functional brain injury will have occurred within the past 24 hours upon admission
 to the ED.

 -  The 'head injured' control group will be males and females ages 18 to 80 (the entire
 age range), who are admitted to the ED and are suspected or who have sustained a head
 injury but do not report or manifest symptoms, e.g. facial lacerations and/or
 whiplash.

 -  The ED normal control group will be males and females ages 18 to 80 (the entire age
 range), who are admitted to the ED for presenting complaints that do not involve the
 head or neck (no trauma above the clavicles) and no history of Road Traffic Accident
 requiring an ED visit or TBI within the last one (1) year and no primary complaint of
 syncope.

 Exclusion Criteria:

 -  Subjects will be excluded who have forehead, scalp, or skull abnormalities or other
 conditions that would prevent correct application of the electrode headset on the
 skin. In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis,
 seizure disorder, brain tumours, history of brain surgery, psychiatric disorder for
 which there is a prescribed psychiatric medication taken on a daily basis, substance
 dependence, history of TIA or stroke within the last year, currently receiving
 dialysis or in end-stage renal disease, active fever defined as greater than 100
 degrees F or 37.7 degrees C, current condition is listed as "critical", subject is
 suffering from an open head injury, subject requires advanced airway management (i.e.
 mechanical ventilation), currently receiving procedural sedation medications (e.g.
 benzodiazepine, anaesthetic, NMDA receptor antagonist, or opioid agonist), subjects
 below the age of 18 years, pregnant women, and prisoners will not be eligible for
 study. ED normal control subjects will be excluded if there is a suspected neck injury
 or trauma above the clavicles, a primary complaint of generalized weakness, or a
 primary complaint of headache or migraine.