Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
調査の概要
詳細な説明
Concussions comprise a type of mild traumatic brain injury in which mechanical forces disrupt brain metabolism causing transient neurological symptoms.
At the current time, there is no universally agreed-upon objective biomarker or risk calculator of concussion upon which physicians can prognosticate future risk, identify optimal treatments, and for sports medicine physicians, decide if and when a particular player were safe to be returned to play.
While the majority of patients experience a full recovery within a few weeks of a concussion, several going on to have chronic, debilitating symptoms, and all patients experience a permanently increased risk of experiencing more debilitating and long-lasting symptoms with each subsequent concussion. For certain people with certain genetic (e.g., ApoE status) and psychosocial (e.g., alcohol abuse, depression) risk factors, even a single concussion can put them at greater risk for earlier and more severe forms of dementia decades hence.
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.
This study plans to collect biological specimens (blood, saliva, urine, hair follicles), electrophysiological (EEG, EKG), imaging (HCT, MRI, PET, SPECT), ambulatory (actigraphy), sensory thresholds (Von Frey), ophthalmologic (fundoscopic photographs, OCT, SSVEPs), vestibular (ENG, BESS, BioSway) along with demographic, medical history, medication, psychosocial data and the results on validated instruments of cognition, mood, sleep, head discomfort and quality of life.
Because it is important to determine the variability not only within the concussion group but also between groups, the investigators will also recruit a control cohort, specifically athletes who are already undergoing baseline cognitive testing pre-season. The clinical focus of this study will be on concussed athletes, both children and adults, and the investigators will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19112
- 募集
- Jefferson Comprehensive Concussion Center
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コンタクト:
- Mijail Serruya, MD, PhD
- 電話番号:267-463-2300
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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:
- All patients, 10 years of age or older with concussion being evaluated at the Jefferson Comprehensive Concussion Center in Philadelphia, PA, or by Jefferson Comprehensive Concussion Center physicians at other locations (including Rothman Institute sports medicine clinics in Bryn Mawr, PA, Marlton, NJ, Washington Township, NJ). The target population will be those with suspected concussions.
Exclusion Criteria:
- Patients not presenting at the Jefferson Comprehensive Concussion Center or affiliated locations.
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 |
|---|---|
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Concussed patients
The clinical focus of this study will be on concussed athletes, both children and adults, and we will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure.
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Study groups are differentiated based on presence of concussion.
No intervention is being made in either population (observational study)
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Non-concussed patients
Cohort control.
Primarily athletes who undergo routine pre-season baseline assessment
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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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Medical history indicative of concussion
時間枠:Upon enrollment
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Basic medical history demographics gathered during patient's regular clincal visit.
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Upon enrollment
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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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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Sports Concussion Assessment Tool (SCAT-3)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Balance Error Scoring System (BESS)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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King Devick Test
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Acute Concussion Evaluation (ACE)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Beck Depression Inventory (BDI)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Beck Anxiety Inventory (BAI)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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World Health Organization-Five Well-being Index (WHO-5)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Multidimensional Anxiety Scale for Children (MASC)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Spence Children's Anxiety Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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"SCARED" Montgomery-Åsberg Depression Rating Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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ImPACT
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Trails A and B Forward
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Reverse Digit Span
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Jefferson After Concussion Test (JACT)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Rivermead Post Concussion Symptom Questionnaire (RPQ)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Traumatic Brain Injury-Quality of Life (TBI-QOL)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Mayo-Portland Adaptability Inventory (MPAI-4)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Migraine Disability Assessment (MIDAS)
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Fatigue Severity Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Epworth Sleepiness Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
時間枠:1 year
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Pittsburgh Sleep Quality Index
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1 year
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Diagnostic Procedures
時間枠:1 year
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Galvanic skin response
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1 year
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Diagnostic Procedures
時間枠:1 year
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Electrocardiography (EKG)
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1 year
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Diagnostic Procedures
時間枠:1 year
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Electroencephalography (EEG)
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1 year
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Diagnostic Procedures
時間枠:1 year
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Fundoscopy Optical Coherence Tomography (OCT)
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1 year
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Diagnostic Procedures
時間枠:1 year
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Von Frey Sensory Filament Thresholds
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1 year
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Diagnostic Procedures
時間枠:1 year
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BioSway
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1 year
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Biospecimens
時間枠:1 year
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Blood
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1 year
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Biospecimens
時間枠:1 year
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Siliva
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1 year
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Biospecimens
時間枠:1 year
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Urine
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1 year
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Clinically Acquired Imaging
時間枠:1 year
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CT, MRI
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1 year
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Opthalmologic
時間枠:1 year
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Fundoscopic photographs
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1 year
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Opthalmologic
時間枠:1 year
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Optical coherence tomography
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1 year
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Tactile Sensation
時間枠:1 year
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Von Frey sensory thresholds
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1 year
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協力者と研究者
捜査官
- 主任研究者:Mijail Serruya, MD, PhD、TJUH
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。