Status:
COMPLETED
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
Lead Sponsor:
Neurolign
Collaborating Sponsors:
United States Department of Defense
Conditions:
Concussion, Mild
Concussion, Intermediate
Eligibility:
All Genders
19-45 years
Brief 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 pre...
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 Contr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01832714
Start Date
September 1 2013
End Date
November 1 2015
Last Update
July 19 2019
Active Locations (2)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134
2
Madigan Army Medical Center
Tacoma, Washington, United States, 98431