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

NCT01472042 | Completed

• 1 other identifier: ATO-07
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Sports Concussion; Sports Injury

Keywords

Traumatic Brain Injury; Sport Concussion; Head Injury; Sports Injury

Outcome Measures

Primary Outcomes (1)

• Change in levels of TBI biomarkers from baseline

  36 months

Secondary Outcomes (5)

• 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

  Throughout Participation in Study

• Assessment of pituitary status and determination of the presence of autoantibodies.

  36 months

Study Arms (3)

Sports induced concussion

Exposure to sports induced concussion

Other: Banyan Biomarkers

Routine Athletic Exertion

Exposure to routine athletic exertion (non-concussion control)

Other: Banyan Biomarkers

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

Interventions

Banyan Biomarkers OTHER

Biomarkers to detect specific proteins.

Other Non-Penetrating Trauma to the Head; Routine Athletic Exertion; Sports induced concussion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Banyan Biomarkers, Inc: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Whole Blood and Plasma

MeSH Terms

Conditions

Brain Injuries, Traumatic; Athletic Injuries; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jay Clugston, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

US (1)