Novel Protection Against Potential Brain Injury During Competitive Non-helmeted Sport in Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of Participants Completing EEG
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 soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
详细描述
This study will investigate the effectiveness of this device in high school athletes playing a non-helmeted sport such as soccer. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. This study will focus on the use and effectiveness of the device solely in females, as male football and hockey players have previously been investigated. All participants will be outfitted with an adhesive patch-like accelerometer (which will be placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2_x_patch/) which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive soccer 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. At each of these time points participants will also undergo various neurocognitive assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal healthy volunteer
- •Able to provide written consent
- •Must be 14 years or older and a participant on a high school soccer team
排除标准
- •Unable to provide written consent
- •History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
- •Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- •Glaucoma (Narrow Angle or Normal Tension)
- •Hydrocephalus
- •Recent penetrating brain trauma (within 6 months)
- •Known carotid hypersensitivity
- •Known increased intracranial pressure
- •Central vein thrombosis
- •Any known airway obstruction
- •Any known seizure disorder
结局指标
主要结局
Number of Participants Completing EEG
时间窗: 6 months
Number of participants completing EEG
Pre-season to Post-season DTI Percentage Change
时间窗: 6 months
Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.
次要结局
未报告次要终点