Eye-Tracking Rapid Attention Computation (Eye-TRAC)
調査の概要
状態
詳細な説明
The main goal of this project is the development of a military-ready, sensitive and rapid eye tracking diagnostic device for individuals with mild traumatic brain injury (mTBI). The device will also be tested for its efficacy in diagnosing fatigue and identifying aging effects. We will use a predictive visual tracking paradigm to dynamically capture the attentional state and correlate the subject's performance with the degree of disruption in the attention network caused by mTBI, aging and fatigue. The device will be tested for its diagnostic capabilities based on its selectivity, reliability, sensitivity and validity for individuals of varying ages (with and without mTBI) and in military personnel who have undergone 26 hours of sleep deprivation.
Testing will be conducted at two sites:
- Civilians with mTBI; and civilians with adult attention deficit hyperactivity disorder will be tested by trained staff of the Brain Trauma Foundation (BTF) at Weill Cornell Medical College (WCMC) in New York City. The ages of the enrolled individuals will range between 18-55 years in order to examine aging effects.
- Enrolled service members will be tested at the United States Army Research Institute of Environmental Medicine (USARIEM) in Natick, Massachusetts. These service members will be healthy volunteers without a history of mTBI. Some of these subjects will undergo 26 hours of sleep deprivation during which they will be tested at specific time points.
Our objectives are:
1. Prove that the eye-tracking concept can be brought from a successful laboratory device to a specific, reliable, selective, and valid diagnostic tool.
1.1. Test reliability by examining the test-retest reliability measures of EYE-TRAC;
1.2. Test selectivity by testing the ability to differentiating the effects of fatigue, aging, and mTBI on EYE-TRAC measures;
1.3. Test validity by determining the relationship between measures of attention and working memory based on the EYE-TRAC and validated measures of sustained attention and working memory;
1.4. Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate with EYE-TRAC.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10021
- Citigroup Imaging Center, Weill Medical College of Cornell University
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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
Normals:
Inclusion Criteria:
- Healthy volunteer
- Education up to 12th grade
Exclusion Criteria:
- History of concussion or TBI
- Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
- Gross visual or hearing problems
- Pregnancy
- Metal in the body or any contraindications for MRI
TBI Patients:
Inclusion Criteria:
- Education up to 12th grade
- Persistent post concussive symptoms after an isolated incident of head injury with or without loss of consciousness between 3 months to 5 years prior to participation
Exclusion Criteria
- Prior history of seizures
- Pregnant woman
- Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
- Gross visual or hearing problems
- Any metal in the body or contraindications for MRI
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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TBI Patients
Individuals who have suffered a mild traumatic brain injury and have persistent post-concussive symptoms (PCS)
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Normals
Individuals of comparable age and education who have not suffered a traumatic brain injury
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jamshid Ghajar, M.D., Ph.D.、Brain Trauma Foundation
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。