Concussion, Mild Clinical Trial
— NKI-RIF1Official title:
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
Verified date | July 2019 |
Source | Neuro Kinetics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | November 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 45 Years |
Eligibility |
Inclusion criteria for all subjects (Control and mTBI) - Males or females from 19 - 45years
of age and of all races. Additional Inclusion criteria for mTBI Subjects - Diagnosed with traumatic brain injury utilizing 2007 DoD Standard diagnosis of - 1) Exposed to an event, - 2) Suffered alteration or loss of consciousness secondary to the event, and - 3) Had a sequelae from the event. Exclusion criteria for all subjects (Control and mTBI) - Brain injury resulting from a penetrating wound to the head, neck, face or brain (to include gunshot wounds) - Presence of severe aphasia - Persons whom have had an mTBI within the prior month and are symptomatic. - Persons with a previous history of multiple mTBIs and are symptomatic. - History of neuropsychiatric disorders antedating the head injury (e.g. hypochondriasis, major depression, schizophrenia) - Pregnancy - Prior disorders of hearing and balance including: - Meniere's disease - Chronic migraine - Multiple sclerosis - Vestibular neuritis - Vestibular schwannoma - Sudden sensorineural hearing loss - Cerebrovascular disorders - Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc. - Medications which depress the sensorium precluding patient compliance with the testing (considered on a case-by-case basis) - Previous contraindicating surgeries at the discretion of the study physicians or audiologists Additional Exclusion criteria for Control Subjects - Concussion within the last year (12 months) - Repeated blast exposure |
Country | Name | City | State |
---|---|---|---|
United States | Naval Medical Center San Diego | San Diego | California |
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Neuro Kinetics | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variability of latency in reflexive saccades (ms) | Examine the latency of subjects with mTBI with respect to mean latency and standard deviation of control subjects. | within 7 days of a concussion event | |
Primary | Variability of latency in reaction time test (ms) | Examine the latency of subjects with mTBI with respect to mean latency and standard deviation of control subjects. | within 7 days of a concussion event | |
Primary | Variability of error in subjective visual vertical test (degrees) | Examine the mean error of subjects with mTBI with respect to mean error and standard deviation of control subjects. | within 7 days of a concussion event |
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