跳至主要内容
临床试验/NCT02858544
NCT02858544已完成不适用

Concussion in Motor Vehicle Accidents: The Concussion Identification Index

Clionsky Neuro Systems Inc.1 个研究点 分布在 1 个国家目标入组 1,790 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,790
试验地点
1
主要终点
Correlation - Concussion Identification Index score with ImPACT test score

研究概览

简要总结

The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment for concussion.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients injured in a motor-vehicle related accident

排除标准

  • •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

结局指标

主要结局

Correlation - Concussion Identification Index score with ImPACT test score

时间窗: Within 90 days of the accident

次要结局

  • Patient-completed one page questionnaire(Within 90 days of the accident)

研究者

发起方
Clionsky Neuro Systems Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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