Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology

The purpose of the current study is proposed to prospectively validate the BrainScope Ahead®
M-100 device design, performance, and labeling with respect to the device's target intended
use and indications for use:

- Primary Endpoint:

- Structural Injury Assessment

- There are four co-primary endpoints in this study: two sets of sensitivity and
specificity to divide the data into three classes.

- Using a BrainScope classification algorithm, the Ahead® M100 will identify
subjects showing sensitivities among 3 classes: Green-normal, nonhead injured
controls,Yellow-head injured subjects who do not exhibit brain electrical activity
that is consistent with a structural brain injury observable on CT or for whom CT
was not deemed necessary,Red-head injured subjects who exhibit brain electrical
activity consistent with a structural brain injury observable by CT.

- Secondary Endpoint:

- Functional Injury Assessment

- There are two co-secondary endpoints for the secondary objective, the sensitivity
and specificity to split Yellow from the primary endpoint into two sub groups
depending on degree of brain functional impairment observable by an evaluation of
the clinical findings on a clinical charter used as the assessment of truth.

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 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 MVA requiring an ED
visit or TBI within the past 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 tumors, history of brain surgery, mentally retarded, 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 100oF or 37.7oC, current condition is listed as "critical" in the opinion of the
investigator, 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, anesthetic, 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