Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Blast Explosive Waves Experienced During the Training
研究概览
简要总结
The purpose of the study is to monitor changes in brain structure and function between the pre-training and post-training, in a population of tactical team members 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 tactical team members exposed to blast waves during tactical training. Subjects participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2) Non-device wearing during the tactical training. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every concussive blast wave sustained by the subject. Effectiveness of the device will be determined via differences in brain MRI and EEG, vision and hearing testing prior to and following standardized breaching and diversionary device scenario training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy volunteer
- •Able to provide written consent
排除标准
- •Unable to provide written consent
- •History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-tactical training 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
Blast Explosive Waves Experienced During the Training
时间窗: single breacher training day
The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
Average Peak Pressure Differences Between Groups
时间窗: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI
次要结局
- Change in DP-NF Value (Reported in Hz)(Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.)
- Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar(Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.)