Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
Condition: Concussion, Mild; Concussion, Intermediate; Concussion, Severe
MeSH terms: Brain Concussion
Study type: Observational

Summary: 
      This study is designed to evaluate the use of a collection of tests that measure the eye
      response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI. The
      tests use highly precise measurement tools to assess various neurologic functions. (For
      example, high-speed cameras to record eye movement, high-end motors to precisely spin and
      move the subject, comprehensive analysis to stitch together the stimulus and the response.)

      Hypotheses:

        1. A battery of oculomotor, vestibular and reaction time tests will generate variables that
           when properly weighted and run through a given multi-variant analysis, will separate the
           subjects into one of two groups, mTBI or not-mTBI.

        2. A battery of neurologic assessment tests including reaction time, vestibular and
           oculomotor tests taxing a range of neurologic functions and executed using one or more
           of the I-Portal® family of devices, will generate responses that, when used by a trained
           physician, can aid in the diagnosis of an mTBI.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Investigational Group includes Service Members (SM) and civilians who had been
        diagnosed with an mTBI. The Control Group consists of SM and civilians who do not have
        clinical symptoms consistent with mTBI. There will be at least 90 participants in each
        group, for a target total of at least 180 study participants.
      
Keywords: Concussion; mTBI; military; MACE; NKI; NOTC; VNG; VOG; Neuro Kinetics; oculomotor; vestibular; reaction time; I-Portal; eye tracking; Dizziness Handicap Inventory