Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury
Imaging Biomarkers of Delayed Sequelae in Mild to Moderate Traumatic Brain Injury
調査の概要
詳細な説明
This study is being done to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain ("biomarkers") that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a potential link between mild to moderate traumatic brain injury (mTBI) and PD. We will compare findings from persons who experienced mTBI ("cases") to persons without history of brain injury (mTBI-or "controls"). This study may provide preliminary data that might be used to help design future long-term studies.
The investigators propose scientific studies with one specific aim and two hypotheses:
Specific aim: to determine if one year post emergency room (ER) visits, DaTscan uptake (Ioflupane I123 injection and single photon emission computerized tomography) is lower in subjects exposed to mTBI (defined as a closed head trauma that results in loss of consciousness or amnesia for less than 24 hours) than in subjects not exposed to mTBI (without closed head trauma; mTBI-).
Hypotheses:
Hypothesis #1: mTBI is a risk factor for Parkinson's disease (PD). Hypothesis #2: DaTscan is able to detect subclinical PD (as measured by a dopamine transporter deficiency) in mTBI subjects.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Illinois
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Evanston、Illinois、アメリカ、60201
- Northshore University Healthsystem
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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
説明
Inclusion Criteria:
- mTBI or mTBI- survey respondents
- Ages 18-100 years
- Without a history of parkinsonism or tremor
Exclusion Criteria:
- History of parkinsonism or tremor
- Lugol or iodide allergy
- Contraindicated medications for DaTscan
- Pregnancy or nursing mothers
- Renal or liver impairment
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 |
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mTBI
Historical cohort of subjects seen in the emergency rooms of NorthShore University HealthSystem with ICD-9 diagnoses of mild or moderate traumatic brain injury during the years 2006-2011 (7,122 subjects).
100 mTBI+ subjects are randomly selected for clinical assessment and DaTscan.
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mTBI-
Historical cohort of subjects seen in the emergency rooms of NorthShore University HealthSystem with ICD-9 diagnoses of disorders other than mild or moderate traumatic brain injury during the years 2006-2011 (7,122 subjects).
100 mTBI- subjects are randomly selected for clinical assessment and DaTscan.
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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 |
メジャーの説明 |
時間枠 |
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DaTSCAN
時間枠：At least one year post ER visit for mTBI or mTBI-
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We will perform qualitative (visual) and quantitative (DaTQUANT) analyses of striatal uptake.
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At least one year post ER visit for mTBI or mTBI-
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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 |
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clinical assessment
時間枠：At least one year post ER visit for mTBI or mTBI-
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All subjects complete a questionnaire that documents lifelong exposures to mTBI; that screens for parkinsonism, Parkinson's disease, or tremor; and that screens for DaTSCAN exclusion criteria.
We abstract medical records.
Subjects eligible for DaTSCAN undergo the Montreal Cognitive Assessment (MoCA); Ohio State University TBI Identification Method Short Form (OSU-TBI-ID-SF); General Anxiety Disorder 7-item Scale (GAD7); Center for Epidemiological Studies Depression Scale (CES-D); Rivermead Post Concussion Symptoms Questionnaire; Insomnia Severity Index (ISI); World Health Organization Quality of Life-Brief Assessment (WHOQOL-BREF); Review of Systems; Past Medical History; Detailed Examination of Motor Function-Unified Parkinson's Disease Rating Scale (UPDRS part III); Neurological Examination; Syndromic Classification (parkinsonism, essential tremor, mild cognitive impairment); Differential Diagnosis of Parkinsonism (if applicable); Final Diagnosis of Parkinsonism (if applicable).
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At least one year post ER visit for mTBI or mTBI-
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協力者と研究者
協力者
捜査官
- 主任研究者：Demetrius M Maraganore, MD、Northshore University Healthsystem
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 (実際)
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
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