Concussion in Motor Vehicle Accidents: The Concussion Identification Index (CIDI)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Massachusetts
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Springfield、Massachusetts、アメリカ、01105
- Clionsky Neuro Systems, Inc.
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
|
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.
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Correlation - Concussion Identification Index score with ImPACT test score
時間枠：Within 90 days of the accident
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Within 90 days of the accident
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-completed one page questionnaire
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Mitchell I Clionsky, Ph.D、Clionsky Neuro Systems Inc.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。