NCT01472042

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 265 (actual)
• Sponsor: Banyan Biomarkers, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Traumatic Brain Injury
• Sports Concussion
• Sports Injury

Interventions

Type	Name	Description
OTHER	Banyan Biomarkers	Biomarkers to detect specific proteins.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-11-16
• Last updated: 2016-07-20

Locations

1 site across 1 country: United States