Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- EEG
研究概览
简要总结
Traumatic brain injury (TBI) is one of the most frequent injuries affecting service members. Unfortunately, current neurocognitive assessment tools are unable to reliably detect mild TBI more than a few days post- injury. Therefore, development of advanced systems for assessment and diagnosis of TBI are a top priority within Department of Defense. This project aims to evaluate a combined electroencephalography (EEG) and eye tracking system capable of assessing compromised cognitive function stemming from TBI, with the goal of enhancing operational readiness and aiding in diagnosis, improving health care and rehabilitation for affected military personnel.
详细描述
This study (N=100) will be a correlational study to assess cognitive function in healthy controls, individuals with mild TBI, and individuals with moderate-to-severe TBI.
In general, participants will provide demographic information, medical history, and details of their head injury. Participants will also complete a brief neuropsychological assessment to obtain an index of cognitive ability, along with the Fusion Test with eye tracking and linked EEG. MRI data may also be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All groups:
- •Ability to use dominant hand to complete cognitive and motor tasks
- •Fluent in English
- •Mild TBI group:
- •History of mild TBI > 3 months and < 10 years prior to enrollment
- •Self-report of post-concussive symptoms
- •Moderate-to-Severe TBI group:
- •History of moderate or severe TBI > 3 months and < 10 years prior to enrollment
排除标准
- •Control group:
- •History of possible or confirmed brain injury
- •All groups:
- •History of a medical condition (other than brain injury) that would be expected to affect cognitive or motor abilities (e.g. muscular dystrophy, multiple sclerosis, or psychotic disorders such as schizophrenia)
- •Presence of neurological condition, such as brain tumor, brain infection, seizure, or stroke
- •Presence of visual impairment that is uncorrected by glasses or contacts (including color blindness)
- •Evidence of current suicidal or homicidal ideation
结局指标
主要结局
EEG
时间窗: One study visit
Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.
Eye Tracking
时间窗: One study visit
Saccadic latencies measured in response to cognitive task including working memory demands.
次要结局
- Symbol Search(One study visit)
- Trail Making Test(One study visit)
- Neurobehavioral Symptom Inventory (NSI)(One study visit)
- Digit Span(One study visit)
研究者
Lynita Mullins
Department Head, Physical Medicine and Rehabilitation
United States Naval Medical Center, San Diego