A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes (GATOR)

Banyan International

Status

Completed

Conditions

Traumatic Brain Injury

Sports Concussion

Sports Injury

Treatments

Other: Banyan Biomarkers

Study type

Observational

Funder types

Industry

Identifiers

NCT01472042

ATO-07

Details and patient eligibility

About

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.

Full description

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.

Enrollment

265 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subject is a University of Florida student athlete on a team participating in the study
The Subject is at least 18 years of age at screening (has had their 18th birthday)
The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
It is the Principal Investigator's opinion that based on the knowledge of the Subject that the Subject is an appropriate candidate for the study.

Exclusion criteria

Participating in another clinical study that may affect the results of either study.
Venipuncture not feasible (i.e. skin integrity compromised at the venipuncture sites, blood vessel calcification.
Not available for the end of season follow-up visit.
The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.