跳至主要内容
临床试验/NCT03883451
NCT03883451已完成不适用

Evaluation of Helmet Technology and Head Impact Exposure

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
Change in brain DTI

研究概览

简要总结

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes grouped by helmet make and model. Secondly, the purpose is to determine the protection of the helmet make and model relative to amount and magnitude of sustained head impacts.

详细描述

Sports-related traumatic brain injury (sTBI) is common in competitive sports and recreational activities, with 1.6 to 3.8 million reported annually in the U.S. Children, adolescents and young adults are at the highest risk for sustaining mild TBI. There is scarce high-level prospective, objective evidence indicating that any recent helmet design can prevent sTBI. While helmets were developed for, and are effective in, preventing skull fractures and intracranial hematomas, it is unclear if they afford protection against forces inside the cranium.

This study will investigate the relationship between potential changes in brain structure and function pre and post season compared to helmet make and model and head impact exposure in high school and college athletes playing a collision sport such as football. The use of helmets/headgear during such a high-risk sport will allow for collision measurement devices to be affixed to the athlete under the helmet and will not affect play or fit of equipment. By the nature of the sport selected, it is likely this study will primarily include males, however if any female meets inclusion criteria on the team selected, the participant will be included in this investigation. All participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the helmet model will be determined via differences in longitudinal brain imaging and functional testing following competitive football participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. The investigators will also enroll a group of athletes involved in a non-contact sport (such as cross country) to act as controls.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Normal healthy volunteer
  • Able to provide written consent
  • Must be 13 years or older and a participant on a high school or collegiate team

排除标准

  • Unable to provide written consent
  • Not medically cleared to participate on a high school or collegiate team

结局指标

主要结局

Change in brain DTI

时间窗: 6 months

change in DTI scan of the brain from pre to post season scans targeting specific regions of interest

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验