Traumatic Brain Injury Data for FITBIR Informatics system

描述(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。一些关于脑外伤的出版物，包括那些涉及成像的，已经暗示了潜在的临床和成像生物标记物。然而，对于这些可用于启动药物开发和验证新的治疗干预措施的生物标志物或成像标志物的预后价值，尚未出现明确的图景。在美国国立卫生研究院和美国国防部的努力下，近年来，全美乃至全世界的脑损伤成像研究取得了巨大的增长。自2000年初以来，我们有幸参与了颅脑损伤的研究，S先生的研究产生了大量的临床、行为和先进的磁共振成像数据。如果我们将我们的数据集中到一个单一的统一数据库中，如FITBIR信息系统，我们和更大的TBI研究界将大大受益。这将为我们提供访问不可能在单一地点产生的大量数据，并允许个别调查人员使用新的算法来测试他们的假设。这可能是获得对一种可以采用这种可变路径的疾病具有高敏感性和特异性的成像标记的唯一方法。除了来自常规磁共振的数据，我们可以提供给FITBIR的成像数据包括先进的成像技术，如扩散张量成像、扩散峰度成像、磁共振波谱、动脉自旋标记、高分辨率容量测量、磁化率加权成像以及基于静息状态和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(总共四个时间点)的纵向成像数据。我们还有兴趣测试我们研究的初步结果，以确定我们的结果是否扩展到来自不同机构的更大数据集，因为它们自己的实验差异。对头部的冲击对任何给定位置的影响可能会产生不同的后果，这将取决于几个因素，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学特征。因此，只有用更大的样本量来解释不同的疾病过程，才能得出清晰的图景。像FITBIR这样的数据库可以从不同的研究人员那里收集数据，并继续增加来自未来研究项目的数据，这将极大地有利于对TBI各个方面感兴趣的研究人员。作为一个群体，我们已经接受了使用FITBIR的培训，并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，我们将从FITBIR中受益，因为我们可以获得更大量的DTI、休息状态和体积数据，以进一步研究丘脑和中脑的作用，并了解导致神经退化和修复的不同大脑网络的参与。希望我们和其他脑损伤研究人员都能从这个大型数据库中受益，以识别临床和成像生物标记物，这些标记物可以导致新疗法的开发，并可以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.