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

This study is currently recruiting participants.
Verified February 2012 by Banyan Biomarkers, Inc
Sponsor:
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier:
NCT01472042
First received: September 7, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Sports Concussion
Sports Injury
Other: Banyan Biomarkers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes

Resource links provided by NLM:


Further study details as provided by Banyan Biomarkers, Inc:

Primary Outcome Measures:
  • Change in levels of TBI biomarkers from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of TBI biomarker levels and the Post-Concussion Scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Association of TBI biomarker levels and the Standardized Assessment of Concussion [ Time Frame: Baseline (beginning of Sports season), Active Phase (during Sports Season) and End of Sports Season ] [ Designated as safety issue: No ]
  • Association of TBI biomarker levels and the Balance Error Scoring System [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Throughout Participation in Study ] [ Designated as safety issue: Yes ]
    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.

  • Assessment of pituitary status and determination of the presence of autoantibodies. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum Whole Blood and Plasma


Estimated Enrollment: 500
Study Start Date: November 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472042

Contacts
Contact: Jay Clugston, MD (352) 392-1161

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Banyan Biomarkers, Inc
Investigators
Principal Investigator: Jay Clugston, MD University of Florida
  More Information

No publications provided

Responsible Party: Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier: NCT01472042     History of Changes
Other Study ID Numbers: ATO-07
Study First Received: September 7, 2011
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Banyan Biomarkers, Inc:
Traumatic Brain Injury
Sport Concussion
Head Injury
Sports Injury

Additional relevant MeSH terms:
Athletic Injuries
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014