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| Name | Class |
|---|---|
| National Football League | OTHER |
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This study will assess the effectiveness of a portable goggle system in the diagnosis of mild traumatic brain injury (mTBI) in athletes.
The purpose of this research study is to assess oculomotor, vestibular and reaction time responses in mild traumatic brain injury (mTBI) athletes, as well as healthy individuals. These measurements will be recorded using a portable goggle system (IPAS). The goal is to determine whether this IPAS goggle system is effective at diagnosing mTBI. A secondary goal is to determine whether this IPAS goggle system is effective at ruling out the diagnosis of mTBI in athletes and non-athletes that do not have the condition.
The IPAS is a portable 3D head mounted display. The IPAS goggles are programmed with a series of tests that track eye motions in response to a target. This device has been determined to be a Non-Significant Risk to study participants.
There are three groups of interest in this study: athletes who suffer an mTBI, athletes who do have an mTBI, and healthy non-athletes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTBI athletes | College athletes who undergo an mTBI during the season | ||
| Control athletes | College athletes who do not undergo an mTBI during the season | ||
| Control non-athletes | Control non-athletes with long term follow-up of approximately 4-6 weeks and 3-5 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Vestibular, oculomotor, and reaction time test results | IPAS testing will be conducted by placing the IPAS goggles on the head of a patient and asking the patient to follow instructions while a set of tests is performed. Each of these tests simply involves eye motions in response to a target. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
History of brain injury resulting from a penetrating wound to the head.
Presence of severe aphasia
History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia
Documented neurodegenerative disorders
Pregnancy, [Female candidates will be asked if they are pregnant]
Prior disorders of hearing and balance including:
Cerebrovascular disorders
History of ear operation other than myringotomy tube in the past
Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
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Subjects will be recruited from the population of athletes in the intercollege athletic programs at the University of Miami. This will include athletes in NCAA Sports as well as intercollege club sports. Aged and sex matched controls will be collected from the general student body of the University of Miami.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |