Traumatic Brain Injury Feasibility Study (EPIC-011)

Traumatic brain injury (TBI) is a significant cause of death and disability in the U.S. The
severity of a TBI may range from "mild" (i.e. a brief change in mental status or
consciousness) to "severe" (i.e. an extended period of unconsciousness or memory loss after
the injury). However, most TBI's that occur each year are mild and are commonly called
concussions. Unfortunately, TBI terminology does not adequately describe the injury or
impairment, its treatment, or the resulting outcomes. Due to the complexity of the human
brain, each person's physiology can result in different patterns of impairment and secondary
conditions, requiring different treatment or rehabilitation. The intent of EPIC ClearView™
TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response
Scale to measure electrophysiology associated with TBI

Inclusion Criteria:

Suspected TBI population:

1. Acute head trauma within 24-72 hours of presentation

2. 18-65 age inclusive

3. GCS of 3-15 on initial evaluation in ED

Control population:

1. 18-65 age inclusive

2. GCS score of 15

Exclusion Criteria:

1. Current neurological disease

2. Current severe psychological disorder

3. History of substance or alcohol abuse

4. Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent

5. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)

6. Current treatment to the head/brain (radiation, whole brain therapy, gamma knife)

7. Head injury in the last two years

8. Unwilling to sign informed consent

9. Pregnant or potentially pregnant

10. Pacemaker, automatic implanted cardiac defibrillator or other implanted electrical
device

11. Connected to an electronic device that cannot be removed

12. Missing all or part of fingers or cuts/burns on pads of fingers

13. Long fingernails and unwilling to cut them and keep them cut for the duration of the
study

14. Hand tremors or involuntary oscillations ("shaking") of the hands that prevents clear
imaging

Additional exclusion criteria for control population:

Previous head trauma