Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19112
- 招聘中
- Jefferson Comprehensive Concussion Center
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接触:
- Mijail Serruya, MD, PhD
- 电话号码:267-463-2300
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Medical history indicative of concussion
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Neurocognitive Testing and Assessment Batteries
大体时间: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
大体时间: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
大体时间:1 year
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King Devick Test
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1 year
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Neurocognitive Testing and Assessment Batteries
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:1 year
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ImPACT
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1 year
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Neurocognitive Testing and Assessment Batteries
大体时间: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
大体时间:1 year
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Reverse Digit Span
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1 year
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Neurocognitive Testing and Assessment Batteries
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:1 year
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Fatigue Severity Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
大体时间:1 year
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Epworth Sleepiness Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
大体时间:1 year
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Pittsburgh Sleep Quality Index
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1 year
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Diagnostic Procedures
大体时间:1 year
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Galvanic skin response
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1 year
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Diagnostic Procedures
大体时间:1 year
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Electrocardiography (EKG)
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1 year
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Diagnostic Procedures
大体时间:1 year
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Electroencephalography (EEG)
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1 year
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Diagnostic Procedures
大体时间:1 year
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Fundoscopy Optical Coherence Tomography (OCT)
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1 year
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Diagnostic Procedures
大体时间:1 year
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Von Frey Sensory Filament Thresholds
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1 year
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Diagnostic Procedures
大体时间:1 year
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BioSway
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1 year
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Biospecimens
大体时间:1 year
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Blood
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1 year
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Biospecimens
大体时间:1 year
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Siliva
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1 year
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Biospecimens
大体时间:1 year
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Urine
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1 year
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Clinically Acquired Imaging
大体时间:1 year
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CT, MRI
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1 year
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Opthalmologic
大体时间:1 year
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Fundoscopic photographs
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1 year
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Opthalmologic
大体时间:1 year
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Optical coherence tomography
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1 year
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Tactile Sensation
大体时间:1 year
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Von Frey sensory thresholds
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1 year
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合作者和调查者
调查人员
- 首席研究员:Mijail Serruya, MD, PhD、TJUH
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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