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

A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Sports Injury; Sports Concussion
• Intervention / Treatment: Other: Banyan Biomarkers

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.

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sports induced concussion; Exposure to sports induced concussion	Other: Banyan Biomarkers; Biomarkers to detect specific proteins.
Routine Athletic Exertion; Exposure to routine athletic exertion (non-concussion control)	Other: Banyan Biomarkers; Biomarkers to detect specific proteins.
Other Non-Penetrating Trauma to the Head; Exposure to other non-penetrating trauma to the head that is witnessed or self-reported	Other: Banyan Biomarkers; Biomarkers to detect specific proteins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in levels of TBI biomarkers from baseline	36 months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Banyan Biomarkers, Inc
• Investigators: Principal Investigator: Jay Clugston, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: November 11, 2011
• First Posted (ESTIMATE): November 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Sports Injury; Head Injury; Sport Concussion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Athletic Injuries
• Other Study ID Numbers: ATO-07