The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology (IPAS Goggles) for the Diagnosis of Mild Traumatic Brain Injury (mTBI) in a Community Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of participants with mTBI
研究概览
简要总结
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.
详细描述
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet one of the following inclusion criteria:
- •Males and females from 18-50 years of age who present to the emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic with a history of all of the following: 1) Blow or impact to head, 2) Period of loss or alteration of consciousness, 3) Neurosensory symptoms, and 4) Diagnosis by Emergency Room Staff or Medical Staff of having suffered an mTBI/Concussion.
- •An age- and sex- matched control group also recruited from emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic. These will include individuals with minor injuries (e.g ankle sprains, minor knee injuries, etc.) not involving the head and not requiring admission to the hospital.
排除标准
- •History of head injury characterized by any of the following:
- •Resulting from penetrating trauma
- •Resulting from an automobile accident with significant associated injuries
- •Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
- •Associated with a loss of consciousness period greater than 59 minutes
- •Judged to be more than mild by Medical Staff
- •Requiring admission to the hospital for any reason
- •Associated with subdural or epidural hemorrhage
- •Head injury history
- •For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment
- •For head injured group - history of head injury within the last three months or experiencing head injury symptoms immediately prior to the current head injury
- •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
- •History of Cerebrovascular disorders
- •History of ear operation other than myringotomy and tube placement in the past
- •Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
- •Individuals who cannot provide informed consent
研究组 & 干预措施
Subjects with minor injuries
Individuals who come to the emergency department or urgent/acute care facility with minor injuries (such as ankle sprains or knee sprains) will undergo testing with the I-PAS Goggles.
干预措施: I-PAS Goggles (Device)
Subjects with mTBI
Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.
干预措施: I-PAS Goggles (Device)
结局指标
主要结局
Number of participants with mTBI
时间窗: 33 months
How many participants were detected to have mTBI following an injury.
次要结局
- Time to recover(33 months)
研究者
Michael E. Hoffer
Professor
University of Miami