Closed-Loop Functional Diffuse Optical Tomography (fDOT) Imaging System for Traum

描述（由申请人提供）：我们计划扩大开发和临床验证闭环功能神经成像系统，用于评估创伤性脑损伤（TBI）受试者。被认为是功能性漫射光学断层成像（fDOT）成像系统提供了一个全面的解决方案，可以实时地从头部区域探索与事件相关的血流动力学响应。在第一阶段的支持下，一种新型头盔设计的开发支持了这种能力，这种头盔设计可以容纳密集的光纤阵列，并且可以快速轻松地适应几乎任何头部几何形状的检查。与此能力相辅相成的是仪器系统能力和分析软件的显著进步。另一个重要的进步是开发了一种可编程的头形校准幻影，它可以准确地模拟任何时变的血流动力学响应，具有高保真度和时间精度。这种能力是通过使用电致变色材料实现的，这种材料的光学特性可以通过调节驱动电压来快速准确地调制。通过简单地编程漫射光学组织模拟器（DOTS）幻影来模拟感兴趣的临床表现，真实的图像特征可以可靠地与伪影区分开来。这种独特的专利能力代表了在获得复杂生理状态的客观和常规系统验证方面的重大进步。实验计划要求改进我们的数据收集硬件，更新我们的仪器和分析软件，以便(i)支持更大规模数据集的检查，（ii）允许将图像特征映射到潜在的解剖结构，并随后进行临床研究，探索健康志愿者和TBI受试者的执行功能（工作记忆，语言启动）的不同方面。我们将对这些结果进行分析，以生成所选参数组差异的统计图，从中我们可以得出基于多变量分析方法的复合测量。最后，我们将通过比较fDOT图像结果与fMRI和临床结果以及使用DOTS模型获得的结果来独立验证图像结果。该计划的发展将补充我们已经先进的成像系统，该系统已经吸引了全球11个领先研究中心使用的系统日益增长的需求。我们相信，经过深思熟虑的系统设计和功能将为TBI的临床管理和神经科学界开辟一个巨大的市场机会。

DESCRIPTION (provided by applicant): We plan to expand the development and clinically validate a closed-loop functional neuroimaging system for the purpose of evaluating subjects with traumatic brain injury (TBI). The considered functional Diffuse Optical Tomography (fDOT) imaging system offers a comprehensive solution to the problem of exploring, in real-time, event related hemodynamic responses from essentially area of the head. Supporting this capability has been the development, under Phase I support, of a novel helmet design that can accommodate dense arrays of optical fibers and that can be quickly and easily adapted to comfortably examine essentially any head geometry. Complementing this capability has also been significant advances in instrument system capabilities and analysis software. Still another significant advance, has been the development of a programmable head-shaped calibrating phantom that can accurately mimic essentially any time-varying hemodynamic response with high fidelity and temporal accuracy. This capability is made possible through use of electrochromic materials whose optical properties can be rapidly and accurately modulated by adjustment of the driving voltage. By simply programming the Diffuse Optical Tissue Simulator (DOTS) phantom to mimic clinical findings of interest, true image features can be reliably distinguished from artifact. This unique and patented capability represents a significant advance in the effort to obtain objective and routine system validation of complex physiological states. The experimental plan calls for improvements to our data collection hardware and to update our instrument and analysis software in ways that (i) support examination of larger size data sets and (ii), permit mapping of image features to the underlying anatomy, and to follow this by a clinical study that will explore different aspects of executive function (working memory, language initiation) in healthy volunteers and subjects with TBI. These results will be analyzed to produce statistical maps of group differences for selected parameters from which we can derive composite measures based on multivariate analysis methods. Finally, we will independently validate the image results by comparing the fDOT image findings to fMRI and clinical findings, and to results obtained using our DOTS phantom. The plan development will complement our already advanced imaging system that has attracted growing demand for which systems are in use in eleven leading research centers world-wide. We are confident that the considered system design and capabilities will open a large market opportunity in support of clinical management of TBI and to the neuroscience community. Planned is the development of an inexpensive brain imaging system able to detect and monitor Traumatic Brain Injury, which affects 2.5-6.5 million people and costs an estimated 48.3 billion in the US each year. The core technology will be updated and preliminary results will be followed up with a clinical trial that focuses on analyzing brain function in TBI patients and healthy volunteers. In order to fully validate this technology, results of the clinical trial will be compared to fMRI experiments performed on the same patient population, as well as a dynamic phantom study.