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Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development

2015年8月6日 更新者:Thomas Jefferson University
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.

研究概览

地位

未知

条件

干预/治疗

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

观察性的

注册 (预期的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19112
        • 招聘中
        • Jefferson Comprehensive Concussion Center
        • 接触:
          • Mijail Serruya, MD, PhD
          • 电话号码:267-463-2300

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Individuals ages 10 or older. If the patient has experienced a suspected concussion, must be a patient at the Jefferson Comprehensive Concussion Center.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
Study groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study)
Non-concussed patients
Cohort control. Primarily athletes who undergo routine pre-season baseline assessment

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
Medical history indicative of concussion
大体时间:Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
Upon enrollment

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
Sports Concussion Assessment Tool (SCAT-3)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Balance Error Scoring System (BESS)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
King Devick Test
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Acute Concussion Evaluation (ACE)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Beck Depression Inventory (BDI)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Beck Anxiety Inventory (BAI)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
World Health Organization-Five Well-being Index (WHO-5)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Multidimensional Anxiety Scale for Children (MASC)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Spence Children's Anxiety Scale
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
"SCARED" Montgomery-Åsberg Depression Rating Scale
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
ImPACT
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Trails A and B Forward
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Reverse Digit Span
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Jefferson After Concussion Test (JACT)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Rivermead Post Concussion Symptom Questionnaire (RPQ)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Traumatic Brain Injury-Quality of Life (TBI-QOL)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Mayo-Portland Adaptability Inventory (MPAI-4)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Migraine Disability Assessment (MIDAS)
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Fatigue Severity Scale
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Epworth Sleepiness Scale
1 year
Neurocognitive Testing and Assessment Batteries
大体时间:1 year
Pittsburgh Sleep Quality Index
1 year
Diagnostic Procedures
大体时间:1 year
Galvanic skin response
1 year
Diagnostic Procedures
大体时间:1 year
Electrocardiography (EKG)
1 year
Diagnostic Procedures
大体时间:1 year
Electroencephalography (EEG)
1 year
Diagnostic Procedures
大体时间:1 year
Fundoscopy Optical Coherence Tomography (OCT)
1 year
Diagnostic Procedures
大体时间:1 year
Von Frey Sensory Filament Thresholds
1 year
Diagnostic Procedures
大体时间:1 year
BioSway
1 year
Biospecimens
大体时间:1 year
Blood
1 year
Biospecimens
大体时间:1 year
Siliva
1 year
Biospecimens
大体时间:1 year
Urine
1 year
Clinically Acquired Imaging
大体时间:1 year
CT, MRI
1 year
Opthalmologic
大体时间:1 year
Fundoscopic photographs
1 year
Opthalmologic
大体时间:1 year
Optical coherence tomography
1 year
Tactile Sensation
大体时间:1 year
Von Frey sensory thresholds
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mijail Serruya, MD, PhD、TJUH

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年3月1日

初级完成 (预期的)

2016年12月1日

研究完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2015年3月25日

首先提交符合 QC 标准的

2015年8月6日

首次发布 (估计)

2015年8月11日

研究记录更新

最后更新发布 (估计)

2015年8月11日

上次提交的符合 QC 标准的更新

2015年8月6日

最后验证

2015年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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