NCT03515967撤回不适用
The Use of a Portable 3D Head Mounted Display With Integrated Eye Capture Technology (I-PAS) for the Objectification and Quantification of Signs and Symptoms Associated With the Diagnosis of Mild Traumatic Brain Injury (mTBI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with mTBI
研究概览
简要总结
Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).
- •Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
- •Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby.
排除标准
- •History of brain injury resulting from a penetrating wound to the head.
- •Presence of aphasia and/or inability to give informed consent for participation
- •History of diagnosed neuropsychiatric disorders
- •Documented neurodegenerative disorders
- •Prior disorders of hearing and balance including:
- •Meniere's disease
- •Multiple sclerosis
- •Vestibular neuritis
- •Vestibular schwannoma
- •Sudden sensorineural hearing loss
- •Cerebrovascular disorders
- •History of ear operation other than myringotomy tube in the past
- •Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
- •Presence of intra-cranial structural findings on imaging studies
结局指标
主要结局
Number of participants with mTBI
时间窗: 45 months
How many participants were detected to have mTBI following a sports-related injury
次要结局
- Time to recover(45 months)
研究者
Michael E. Hoffer
Professor
University of Miami
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