Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
調査の概要
状態
詳細な説明
This will be a prospective study of subjects with MTBI, body injury and healthy controls. Subjects who meet the study criteria will be enrolled in the study after they provide informed consent.
All subjects will be followed longitudinally at 3 and 6 months post-injury.
All subjects will have 3-4 visits:
Screening visit to determine eligibility; first study visit within 1 month of injury for those with brain or body injury (at the time of screening or within 1 month of screening for healthy controls); second study visit at 3 months post-injury (3 months after the first visit for healthy controls) and third study visit at 6 months post-injury (6 months after the first visit for healthy controls).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Johns Hopkins Bayview Medical Center
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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:
Individuals with MTBI: Inclusion Criteria:
- Have sustained a closed head injury, defined as externally inflicted trauma without skull fracture;
- Have a Glasgow Coma Scale (GCS) score 13 or above
- Meet the American Congress of Rehabilitation Medicine criteria for mild traumatic brain injury
- Have experienced the last injury within 1 month
- Be in excellent/good medical health as assessed by the General Medical Health Rating (GMHR) scale
- Have sufficient cognitive capacity to provide informed consent
- Be between 18-65 years of age and
- Be willing to have brain MRI and a blood draw,
Individuals with Body Injury will meet inclusion criteria 4-8. Instead of criteria for head injury (1-3) they would have had body injury (defined as injury below the neck (e.g., limb fractures, stab wound abdomen).
Age, and sex, matched normal controls: Inclusion Criteria:
- No history of head injury or any other types of brain injury
- Inclusion criteria 5-8
Exclusion Criteria:
- History of stroke, seizures or other pre-injury neurological diseases
- Mental Retardation
- History of skull fracture
- Presence of severe unstable medical disease
- Contraindications to the MRI brain scan
- Possibility of pregnancy
- Presence of communication difficulties, such as moderate to severe hearing or language 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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Mild Traumatic Brain Injury
This cohort will have sustained a closed head injury, defined as externally inflicted trauma without skull fracture within the last month.
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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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Specific biomarkers (alone or in combination) assessed 3 months after MTBI
時間枠:3 months after MTBI.
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This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/MTBI.
This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
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3 months after MTBI.
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Specific biomarkers (alone or in combination) assessed 6 months after MTBI.
時間枠:6 months after MTBI
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This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/MTBI.
This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
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6 months after MTBI
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Vani Rao, MD、Johns Hopkins University
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。