The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology for the Diagnosis of Dizziness Associated With Mild Traumatic Brain Injury (mTBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Vestibular, oculomotor, and reaction time test results
研究概览
简要总结
This study will assess the effectiveness of a portable goggle system in the diagnosis of mild traumatic brain injury (mTBI) in athletes.
详细描述
The purpose of this research study is to assess oculomotor, vestibular and reaction time responses in mild traumatic brain injury (mTBI) athletes, as well as healthy individuals. These measurements will be recorded using a portable goggle system (IPAS). The goal is to determine whether this IPAS goggle system is effective at diagnosing mTBI. A secondary goal is to determine whether this IPAS goggle system is effective at ruling out the diagnosis of mTBI in athletes and non-athletes that do not have the condition.
The IPAS is a portable 3D head mounted display. The IPAS goggles are programmed with a series of tests that track eye motions in response to a target. This device has been determined to be a Non-Significant Risk to study participants.
There are three groups of interest in this study: athletes who suffer an mTBI, athletes who do have an mTBI, and healthy non-athletes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females from 18 - 40 years of age who participate in intercollegiate athletics at the University of Miami to include all levels of sports whether NCAA or club. Initial recruitment will include high intensity sports alone (these include but are not limited to football, Men's and Women's Soccer, Men's and Women's Basketball, Men's Baseball and Women's Softball, and club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).
排除标准
- •History of brain injury resulting from a penetrating wound to the head.
- •Presence of severe aphasia
- •History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia
- •Documented neurodegenerative disorders
- •Pregnancy, [Female candidates will be asked if they are pregnant]
- •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.
结局指标
主要结局
Vestibular, oculomotor, and reaction time test results
时间窗: 3 months
IPAS testing will be conducted by placing the IPAS goggles on the head of a patient and asking the patient to follow instructions while a set of tests is performed. Each of these tests simply involves eye motions in response to a target.
次要结局
未报告次要终点
研究者
Michael E. Hoffer
Professor of Otolaryngology
University of Miami