Validation of Brain Function Assessment Algorithm for mTBI From Initial Injury to Rehabilitation

EEG and clinical data will be collected to develop algorithms for the age group 13-25 years
which will enable the sponsor to refine and validate existing algorithms for the adult
populations. Subjects will come from the sports and other populations of concussed
individuals. They will be matched with controls who will also undergo the same set of tests.

This study will develop an algorithm which will then help to validate/refine the existing
algorithm (18-85 years of age) to apply to the 13-25 year old population.

Inclusion Criteria:

• Age ≥13 and <25 years old;

For Injured subjects:

- Having sustained a traumatic closed head injury within 72 hours (3 days) from time of
injury at time of BrainScope assessment;

- GCS 13-15 at time of BrainScope assessment;

- No hospital admission due to either head injury or collateral injuries for >24 hours.

For Matched Controls:

- GCS 15 at time of BrainScope assessment;

- No prior history of concussion or TBI in the last year.

Exclusion Criteria:

- Previously enrolled in the BrainScope CAS Studies;

- Current CNS active prescription medications taken daily, with the exception of
medications being taken for the treatment of Attention Deficit Disorder (ADD) or
Attention Deficit Hyperactivity Disorder (ADHD);

- Forehead, scalp or skull abnormalities that prevents headset application or EEG data
collection;

- History of brain surgery or neurological disease;

- Pregnant women;

- Subjects who do not speak English (non-English speaking parents are allowed to consent
so long as translation of the consent form in their native language is available);

- Acute intoxication;

- Evidence of illicit drug usage;

For Injured subjects:

- Loss of consciousness ≥ 20 minutes related to the concussion injury;

- Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope
assessment;

- Evidence of abnormality visible on Computerized Tomography (CT) of the head related to
the traumatic event (Note: neuroimaging is not required for enrollment).

For Matched Controls:

- Any focal neurological signs including aphasia, apraxia, diplopia, facial droop,
dysarthria/slurred speech;

- History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within
the past 1 year.