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临床试验/NCT01472042
NCT01472042已完成不适用

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

Banyan Biomarkers, Inc1 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
265
试验地点
1
主要终点
Change in levels of TBI biomarkers from baseline

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in levels of TBI biomarkers from baseline

时间窗: 36 months

次要结局

  • Association of TBI biomarker levels and the Post-Concussion Scale(36 months)
  • Assessment of pituitary status and determination of the presence of autoantibodies.(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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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