Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event

The study uses a prospective, between-subjects design comparing an Investigational (mTBI) Group to a Control Group. The Investigational Group includes SM who had been diagnosed with an mTBI. The Control Group consists of SM who do not have clinical symptoms consistent with mTBI. There will be 90 participants in each group, for a target total of 180 study participants

Existing mTBI evaluation tools will be used to qualify the type and severity of a patient's mTBI symptoms. After the volunteer has been assessed by a physician, the following questionnaires and screening tools will be administered:

• Demographic, included control and patient demographics, education, military service, see Appendix A;
• History of health problems and treatments included medication and mTBI history and stress level before testing, including page 1 of MACE, see Appendix B; History of health problems and treatments included medication and mTBI history and stress level before testing, including page 1 of MACE, used for seconds and third tests only, see Appendix B1;
• Glasgow Coma Scale, use only in 24 hrs after accident, see Appendix C;
• Functional Gait Assessment(FGA) - This is an assessment where the individual is asked to perform ten gait tasks. Each gait task is scored by a trained observer on a 0-3 scale (with 0 being could not perform and 3 being performed well). The individual will end up with a total FGA of between 0-30. The test is very sensitive for demonstrating balance dysfunction and improvement.(see Appendix D)
• Trail Making Test (TMT) - This test is a cognitive test in which subjects use a pencil to draw a line between an ordered series of letters or letters/numbers on a paper. Subjects are instructed to follow the appropriate order without lifting the pencil from the paper. Time to completion is a sensitive measure of cognitive performance. (see Appendix E)
• Dizziness Handicap Inventory,(DHI)-This validated questionnaire is commonly used by clinicians to qualify and quantify symptoms associated with dizziness, light-headedness, vertigo, migraine associated dizziness, and to assist with identifying complaints of dizziness related to anxiety, depression, post-traumatic-stress disorder, etc. This tool will capture subjective symptoms associated with mTBI prior to completing the objective measures (see Appendix F)

Device will be comprehensive oculomotor/ neuro-otologic testing system. System components:

• Motorized Chair that can move in up to 3 axis
• Full field Optokinetic stimulus
• Pursuit Tracker™ - laser target generator
• Isolation enclosure
• Patient monitoring and communication technology

FDA classification: The NOTC is covered under an FDA 510K, and certified to standards 60601-1, 60601-1-1, 60601-1-2, and 60601-1-4.

Modifications to approved device:

Included by manufacturer:

1. A new function to existing buttons for reaction time test
2. Audio stimulus for audio reaction time test
3. 2 stationary LED's installed inside enclosure ceiling for crHIT test

Investigational software which incorporates newly defined oculomotor and reaction time tests designed to investigate mTBI will be installed on the device.