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

Traumatic Brain Injury Clinical Trial

— GATOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472042
• Other study ID #: ATO-07
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: July 18, 2016
• Start date: November 2011
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Banyan Biomarkers, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Injuries
• Sports Concussion
• Sports Injury
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Banyan Biomarkers
Biomarkers to detect specific proteins.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Banyan Biomarkers, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in levels of TBI biomarkers from baseline		36 months	No
Secondary	Association of TBI biomarker levels and the Post-Concussion Scale		36 months	No
Secondary	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	No
Secondary	Association of TBI biomarker levels and the Balance Error Scoring System		36 months	No
Secondary	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	Yes
Secondary	Assessment of pituitary status and determination of the presence of autoantibodies.		36 months	No