Concussion in Motor Vehicle Accidents: The Concussion Identification Index (CIDI)
研究概览
地位
条件
详细说明
This Phase 2 study, Concussion in Motor Vehicle Accidents - The Concussion Identification Index (CIDI), focuses on the psychometric properties of the relationship between acute injury events, i.e. head impact, loss of consciousness (LOC), and post-traumatic amnesia (PTA), commonly reported post-crash signs and symptoms, and neurocognitive outcomes.
Cohort 1 is the validation group and will be used to confirm the optimal cut-off score of the Concussion Identification Index (CIDI) with the score on the ImPACT.
Cohort 2 is the cross-validation group.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Springfield、Massachusetts、美国、01105
- Clionsky Neuro Systems, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Cohort 1 - Validation Group: Consecutive patients who presented for care between November 1, 2013 and December 31, 2014 at the MVA Center for Rehabilitation, a public health clinic in Springfield, MA which provides specialized outpatient auto accident treatment and rehabilitation
Cohort 2 - Cross Validation Group: Consecutive patients who presented for care between January 1, 2015 and June 30, 2016 at the MVA Center for Rehabilitation, a public health clinic in Springfield, MA
描述
Inclusion Criteria:
- Patients injured in a motor-vehicle related accident
Exclusion Criteria:
- Age younger than 10 years old or older than 60 years of age
- Patients who presented for initial evaluation of injuries greater than 90 days after MVA occurred
- Patients who declined to take a computerized neurocognitive test battery
- Patients who were not fluent in either English or Spanish
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Group1 - Validation Group
n=890 patients seen and evaluated for possible concussion after a motor vehicle accident.
Patients with qualifying scores on the Concussion Identification Index will also complete the ImPACT.
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Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
Patient- completed computerized neurocognitive test battery
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Group 2 - Cross Validation Group
n=900 patients seen and evaluated for possible concussion after a motor vehicle accident.
Patients with qualifying scores on the Concussion Identification Index will also complete the ImPACT.
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Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
Patient- completed computerized neurocognitive test battery
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Correlation - Concussion Identification Index score with ImPACT test score
大体时间：Within 90 days of the accident
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Within 90 days of the accident
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient-completed one page questionnaire
大体时间：Within 90 days of the accident
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The questionnaire is divided into two parts: The Injury Characteristics section: asks for a yes-no indication of whether 5 concussion-associated events/injuries occurred: striking the head, whiplash, loss of consciousness, being dazed, or having post-traumatic amnesia; and, whether or not the patient had already been given a diagnosis of concussion. The Concussive Symptoms section asks the patient to rate on a scale of 0-3 the presence and severity of 10 cognitive and emotional symptoms associated with a post-concussion diagnosis. The total numeric value for each patient is reported as an indexed score. |
Within 90 days of the accident
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合作者和调查者
调查人员
- 首席研究员：Mitchell I Clionsky, Ph.D、Clionsky Neuro Systems Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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