Oculomotor Assessment of Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC)
研究概览
简要总结
The purpose of the proposed study is to compare the sensitivity and specificity of three oculomotor test devices in normal subjects versus subjects with history of TBI. The study is designed as a prospective research project in which a group of 120 normal controls without a history of TBI will be compared to another group of 120 participants (total of 240) who have a confirmed history of TBI. Each participant will complete the TBI assessment protocol for each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the devices will be counter-balanced across participants. Participants will also be screened for vestibular migraine and visual vertigo, which are two conditions that influence oculo-vestibular perception in normal and TBI patients and might influence the results from the three oculomotor devices. Data from each device will be utilized to perform AUC analyses to determine the respective sensitivity and specificity for each.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between 18 and 45 at time of screening (upper age restriction is to prevent confounding with age-related physiological changes).
- •Must be able to provide written informed consent.
- •Must be able to read and understand questionnaires and consent forms.
- •Must have corrected binocular acuity of at least 20/40 for near distance with or without single-power corrective lenses or contacts and absent of ocular injury or disease.
- •Control Group - No history of TBI or any history of severe or penetrating TBI
- •TBI Group - Must have a documented history of a TBI occurring within the last 10 years.
排除标准
- •Current or previous neurological disease, including: stroke, congenital brain malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure (other than febrile seizure).
- •Current or previous ocular disease/injury, including: Glaucoma or increased pressure in the eyes, structural damage to ocular tract and ocular cortex, etc.
- •History of vestibular disorder (e.g., with symptoms of clinical vertigo)
- •Binocular vision not correctable to 20/40 for near distance
- •Use of tobacco or caffeinated products less than four hours before test session
- •Consumption of alcohol within past 24 hours
结局指标
主要结局
Area Under the Curve (AUC)
时间窗: Single test session (1.5 hours) - all testing performed at time of study enrollment, will be reported at conclusion of data collection as all data is required to generate AUCs.
Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI)
次要结局
未报告次要终点
研究者
Dr. John King
Audiologist
Walter Reed National Military Medical Center