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

描述(申请人提供)：我们计划扩大开发和临床验证闭环系统的功能神经成像系统的目的是评估创伤性脑损伤(TBI)的受试者。被考虑的功能扩散光学断层扫描(FDOT)成像系统提供了一个全面的解决方案，以实时探索事件相关的血流动力学反应，从主要区域的头部。支持这一能力的是在第一阶段支持下开发的一种新型头盔设计，该设计可以容纳密集的光纤阵列，并且可以快速而轻松地调整以基本上舒适地检查任何头部几何形状。与这一能力相辅相成的还有仪器系统能力和分析软件方面的重大进步。另一项重大进展是开发了一种可编程的头形校准体模，该体模基本上可以高保真度和时间精确度准确地模拟任何时变的血流动力学反应。这种能力是通过使用电致变色材料实现的，其光学特性可以通过调整驱动电压来快速和准确地调制。通过简单地对漫反射光学组织模拟器(DOTS)模体进行编程来模拟感兴趣的临床发现，可以可靠地区分真实图像特征和伪影。这一独特的专利能力代表着在努力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。该实验计划要求改进我们的数据收集硬件，并更新我们的仪器和分析软件，以(I)支持更大规模的数据集的检查，以及(Ii)允许将图像特征映射到潜在的解剖结构，并在此之后进行临床研究，探索健康志愿者和脑外伤受试者执行功能的不同方面(工作记忆、语言启动)。这些结果将被分析，以产生选定参数的组差异统计图，我们可以从这些图中得出基于多元分析方法的综合衡量标准。最后，我们将通过将FDOT图像结果与fMRI和临床结果以及使用我们的DOTS体模获得的结果进行比较，独立地验证图像结果。这项计划的开发将补充我们已经先进的成像系统，该系统已经吸引了越来越多的需求，这些系统正在世界各地的11个领先研究中心使用。我们相信，经过深思熟虑的系统设计和能力将为脑损伤的临床管理和神经科学界打开一个巨大的市场机会。 计划开发一种廉价的脑成像系统，能够检测和监测创伤性脑损伤，美国每年有250万至650万人受到影响，估计花费483亿美元。将更新核心技术，并将跟进初步结果，进行临床试验，重点分析脑外伤患者和健康志愿者的脑功能。为了充分验证这项技术，临床试验的结果将与在同一患者群体上进行的功能磁共振实验以及动态模型研究进行比较。

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.