Concussion, Mild Clinical Trial
Official title:
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
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.
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 Trackerâ„¢ - 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.
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