Clinical trial NCT01472042: A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
Official title: A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Sports Concussion
Sports Injury
Keywords: Traumatic Brain Injury
Sport Concussion
Head Injury
Sports Injury
Lead sponsor: Banyan Biomarkers, Inc
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in levels of TBI biomarkers from baseline
timeFrame: 36 months
Secondary outcomes:
measure: Association of TBI biomarker levels and the Post-Concussion Scale
timeFrame: 36 months
measure: Association of TBI biomarker levels and the Standardized Assessment of Concussion
timeFrame: Baseline (beginning of Sports season), Active Phase (during Sports Season) and End of Sports Season
measure: Association of TBI biomarker levels and the Balance Error Scoring System
timeFrame: 36 months
measure: Safety
timeFrame: Throughout Participation in Study
measure: Assessment of pituitary status and determination of the presence of autoantibodies.
timeFrame: 36 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jay Clugston, MD
role: PRINCIPAL_INVESTIGATOR
References: