Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
The objectives of the study are to document device performance with respect to the primary
 and secondary endpoints.
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