Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 主要终点
- Receiver-operator-curve area under the curve (AUC)
研究概览
简要总结
Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.
详细描述
This was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. These results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. This represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.
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 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Military personnel
- •Age 18 to 45
- •Diagnosis of mTBI within past 5 years
- •Rancho Los Amigos Scale score of 7 or above
排除标准
- •Non-military individuals
- •Below age 18 or older than 45
- •No diagnosis of mTBI within past 5 years
- •Rancho Los Amigos Scale score of 6 or below
结局指标
主要结局
Receiver-operator-curve area under the curve (AUC)
时间窗: up to 5 years
Each test's discrimination capability was quantified using AUC and p value
次要结局
未报告次要终点
