Evaluation of an EEG Based Concussion System

This study will evaluate the accuracy of a new concussion system at detecting concussions.
The investigators will be evaluating the degree to which data collected with the device
agrees with a physician's determination of a concussion. The system captures an
electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual.
The device is not FDA approved, but it is a non-significant risk device. The device is a
non-invasive, non-interventional sensor. It will not replace the opinion of the physician in
diagnosing a concussion.

This study will test the EEG based concussion system on 200 individuals, Participants will be
made up of individuals who are seeking medical consultation at the Play Safe Concussion
Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave,
New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients
who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The
doctors who see patients these locations will be involved in conducting this research. In
addition to the standard-of-care clinical assessments, participants will also receive an
evaluation from the concussion based system.

When a subject experiences a head trauma, the subject will be evaluated for a concussion by
both the standard-of-care clinical assessments. The treating physician will provide all
necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose
and treat each patient and by the new concussion system. Participants will then return to
either the Concussion Clinic or Mount Sinai 2, 4, 7, 14 and 28 days after the day of their
initial head injury to complete the routine follow-up sessions with their treating physician
and to complete additional evaluations with the EEG based concussion system. The researchers
will also collect data from healthy, age-matched controls in order to collect a database of
healthy responses to the technology.

To determine how accurate the new concussion system is at detecting concussions, the research
team will compare the diagnostic results from the device to the diagnostic results of the
doctor's assessments. The goal of this study is to develop a device that can give sound
advice as to whether an individual should seek medical attention for a possible concussion
following a head injury.