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The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports.
Concussion or mild traumatic brain injury (mTBI) is a condition that affects hundreds of thousands of patients worldwide. It is a biomechanically induced neurological injury, resulting in an alteration of mental status, such as confusion or amnesia, which may or may not involve a loss of consciousness. Concussion affects about 1.6 million to 3.8 million athletes yearly, most commonly in contact sports such as American football and boxing. Early clinical effects of concussion include but are not limited to behavioral changes, impairments of memory and attention, headache, unsteadiness, and rarely, catastrophic severe brain injury (sometimes described as second impact syndrome). More recently, the consequences of repetitive mTBI from multiple concussions in a sports setting are becoming evident. Repeated concussions have been associated with greater severity of symptoms, with longer recovery time, and chronically with earlier onset of age-related memory disturbances and dementia. As a result and in contradistinction to the decades-earlier perception that these injuries were benign, sports medicine professionals are now increasingly being instructed to recognize and manage concussions as soon as they occur. "Understanding the neurobiology of concussion will lead to development and validation of physiological biomarkers of this common injury." These biomarkers (e.g., laboratory tests, imaging, electrophysiology) will then allow for improved detection, better functional assessment and evidence-based return to play recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sports induced concussion | Exposure to sports induced concussion |
| |
| Routine Athletic Exertion | Exposure to routine athletic exertion (non-concussion control) |
| |
| Other Non-Penetrating Trauma to the Head | Exposure to other non-penetrating trauma to the head that is witnessed or self-reported |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banyan Biomarkers | Other | Biomarkers to detect specific proteins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of TBI biomarkers from baseline | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association of TBI biomarker levels and the Post-Concussion Scale | 36 months | |
| Association of TBI biomarker levels and the Standardized Assessment of Concussion | Baseline (beginning of Sports season), Active Phase (during Sports Season) and End of Sports Season |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll athletes at the University of Florida, Gainesville. Teams considered for inclusion in the study are men's football, women's lacrosse and women's soccer.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Clugston, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001265 | Athletic Injuries |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Serum Whole Blood and Plasma
| Association of TBI biomarker levels and the Balance Error Scoring System | 36 months |
| Safety | The safety endpoints include the cumulative procedure-related adverse event-free survival, and cumulative unanticipated procedure-related adverse events. The only potential risks to patients in this study are those that are normally related to routine blood collection. | Throughout Participation in Study |
| Assessment of pituitary status and determination of the presence of autoantibodies. | 36 months |
| D020196 |
| Trauma, Nervous System |
| D014947 | Wounds and Injuries |