Traumatic Brain Injury Data for FITBIR Informatics system

描述（由申请人提供）：创伤性脑损伤（TBI）是平民和军人死亡和残疾的主要原因。几篇关于TBI的出版物，包括涉及成像的出版物，已经暗示了潜在的临床和成像生物标志物。然而，关于这些生物标志物或成像标志物的预后价值，还没有出现明确的画面，这些生物标志物或成像标志物可用于启动药物开发和验证新的治疗干预。由于NIH和国防部的努力，近年来全国和世界范围内的TBI成像研究有了巨大的增长。自2000年初以来，我们有幸参与了TBI研究，产生了大量的临床，行为和先进的MR成像数据。我们和更大的TBI研究社区将显着受益，如果我们把我们的数据集中到一个统一的数据库，如FITBIR信息系统。这将使我们能够访问在单个站点不可能生成的大量数据，并允许单个研究人员使用新的算法来测试他们的假设。这可能是唯一的方法，以达到成像标记物，具有高灵敏度和特异性的疾病，可以采取这种可变的路径。除了常规MR的数据外，我们可以为FITBIR提供的成像数据还包括先进的成像技术，如扩散张量成像、扩散峰度成像、MR波谱、动脉自旋标记、高分辨率体积测量、磁共振加权成像以及静息状态和基于任务的功能磁共振成像。此外，我们还将提供这些患者子集18个月（共4个时间点）的纵向成像数据。我们也有兴趣测试我们的初步研究结果，以确定我们的结果是否可以扩展到其他研究所的更大数据集，因为它们有自己的实验变化。在任何给定位置对头部的撞击的影响都可能产生不同的后果，并将取决于几个因素，包括所涉及的加速力、损伤类型（无论是机械损伤还是爆炸损伤）以及患者的人口统计数据。因此，只有通过更大样本量的研究才能清楚地了解异质性疾病过程。一个像FITBIR这样的数据库，它准备从不同的研究者那里收集数据，并继续从未来的研究项目中添加数据，这对TBI各个方面感兴趣的个人研究者来说是非常有益的。作为一个团队，我们已经接受了使用FITBIR的培训，并且熟悉在必要时创建新的通用数据元素和唯一数据元素。此外，我们将受益于FITBIR，可以获得更大量的DTI，静息状态和体积数据，以进一步研究丘脑和中脑的作用，并了解导致神经退行性变和修复的不同大脑网络的参与。希望我们和其他TBI研究人员都能从这个大型数据库中受益，以确定临床和成像生物标志物，这些生物标志物可以导致新疗法的开发，并可用于纵向监测此类疗法的效果。

DESCRIPTION (provided by applicant): Traumatic brain injury (TBI) is a major cause of death and disability in both civilian and military populations. Several publications regarding TBI including those involving imaging have hinted towards potential clinical and imaging biomarkers. However, no clear picture has emerged regarding the prognostic value of these biomarkers or imaging markers that could be used to initiate drug development and validate novel therapeutic interventions. Thanks to the efforts of NIH and the DOD, in recent years there has been a tremendous growth in TBI imaging research across the nation and worldwide. We have been fortunate to participate in TBI research since early 2000's, which has generated significant amount of clinical, behavioral and advanced MR imaging data. We and the larger TBI research community would significantly benefit if we pool our data into a single unified database such as the FITBIR information system. This would provide us access to a large amount of data that is not possible to generate at single site, and allow individual investigators to test their hypothese using novel algorithms. This may be the only way to arrive at imaging markers that have high sensitivity and specificity for a disease that can take such variable paths. Besides data from conventional MR, the imaging data that we can provide to FITBIR includes advanced imaging techniques such as diffusion tensor imaging, diffusion kurtosis imaging, MR spectroscopy, arterial spin labeling, high-resolution volumetrics, susceptibility-weighted imaging, and resting state and task based fMRI. In addition, we will also be providing longitudinal imaging data across 18 months (four total time points) on a subset of these patients. We are also interested in testing our preliminary findings from our study to determine if our results extend to larger datasets from various other institutes given their own experimental variations. The effect of an impact to the head on any given location can have varied consequences, and will depend on several factors including the acceleration forces involved, type of injury (whether mechanical or blast), and the demographics of the patient. Therefore, a clear picture can only emerge from studies with much larger sample sizes to account for the heterogeneous disease processes. A database such as FITBIR which is poised to collect data from various investigators and continue to add data from future research projects would be enormously beneficial to individual researchers interested in various aspects of TBI. As a group, we have already been trained on the use of FITBIR and are familiar with creating new common data elements and unique data elements when necessary. In addition we will benefit from FITBIR by having access to larger amounts of DTI, resting state, and volumetric data to further study the role of the thalamus and the mid-brain and to understand the involvement of different brain networks that leads to both neurodegeneration and reparation. It is hoped that we and other TBI researchers alike can benefit from this large database to identify clinical and imaging biomarkers that can lead to the development of novel therapies and can be used to monitor the effects of such therapies longitudinally.