Initial validation of a novel pre-screening tool for HIV-associated CNS impairment: The Virtual Driving and CNS Assessment System (VDCA)

项目摘要和摘要 检测HIV相关中枢神经系统损害(HIVCI)的标准范例涉及以下方案 需要训练有素的人员，这些人员通常不切实际，在典型的门诊环境中无法获得。结果, HIVCI通常未被发现或发现较晚，导致生活质量下降和存活率下降。与 需要更早的检测和新的医疗账单代码的可用性，最近推动改变 将认知障碍的早期筛查作为诊断测试的先兆的范例目前正在进行 正在进行中；然而，其能力和范围受到严重限制。因此，迫切需要使 这种在病程早期检测HIVCI的新范式(NIMH部门感兴趣的一个主题领域 艾滋病研究和艾滋病毒神经发病计划)：普遍筛查(不需要训练有素的工作人员) 可靠地将艾滋病毒阳性患者转介到神经心理测验(NP)诊断测试(由训练有素的工作人员进行)。这款SBIR 提出了一种新的价值主张：基于已知函数的通用筛选工具 损伤--驾驶。因此，这个SBIR的长期目标是一个新的虚拟驾驶和CNS 评估系统(VDCA)作为一种有效、低成本、易于管理、普遍适用的筛查系统 HIV阳性患者。为了实现这些目标和发展VDCA，我们将利用(1)我们的 商业上成功的虚拟驾驶测试(VDT)作为开发VDCA的平台；(2)我们团队的 利用驾驶来完成认知、感觉运动和记忆系统的科学知识(包括 与艾滋病毒感染者有牵连)；以及(3)我们独家接触到既定的艾滋病毒+参与者纵向队列。 我们使用脑磁图(MEG)的初步工作支持VDCA作为一种 对认知控制和功能能力的有意义的探索，将成为HIVCI的通用筛查。我们 在追求更大的第二阶段项目之前，提出三个第一阶段目标：目标一：开展研究 生产级版本的VDCA融入了新的驾驶场景，以完成认知、感觉运动和 在我们与MEG的补充工作的指导下，具有相关指标的存储系统；目标2：开展 从德雷塞尔大学现有的和NIMH支持的大学招募HIV+患者的观察性先导研究 纵向队列，以检验VDCA表现可以区分有无参与者的假设 HIVCI--从而提供初步证据支持VDCA作为HIVCI筛查解决方案；目标3：评估 通过利用以下方面的见解在临床环境中实施VDCA的可用性、可行性和障碍 Aim 2实施团队和提供艾滋病毒医疗服务的综合医疗团队 在资源有限的临床环境中。这些见解将为VDCA的实用性和可行性提供支持 作为万能的屏幕，为未来二期的细化、测试和评估确定了方向。

Project Summary and Abstract The standard paradigm for the detection of HIV-associated CNS impairment (HIVCI) involves protocols that require trained personnel, often impractical and unavailable in typical outpatient clinical settings. As a result, HIVCI is often undetected or detected late, leading to a lower quality of life and decreased survival. With the need for earlier detection and the availability of new medical billing codes, a recent push to change the paradigm towards earlier screening of cognitive impairment as a precursor to diagnostic testing is currently underway; however, severely limited in its capability and scope. Therefore, there is an urgent need to enable this new paradigm to detect HIVCI earlier in the disease course (a topic area of interest to NIMH’s Division of AIDS Research and HIV Neuropathogenesis Program): universal screening (not requiring trained staff) to reliably refer HIV+ patients to neuropsychometric (NP) diagnostic testing (by trained staff). This SBIR proposes a novel value proposition: A universal screening tool based on a known functional impairment - driving. Thus, the long-term goal of this SBIR is a new Virtual Driving and CNS Assessment System (VDCA) as a valid, low cost, easy-to-administer, universal screening system for HIV+ patients. To achieve these objectives and develop the VDCA, we will leverage (1) our commercially-successful virtual driving test (VDT) as a platform on which to develop the VDCA; (2) our team’s scientific know-how in utilizing driving to task cognitive, sensorimotor and memory systems (including those implicated in HIVCI); and (3) our exclusive access to an established longitudinal cohort of HIV+ participants. Our preliminary work using magnetoencephalography (MEG) supports the development of the VDCA as a meaningful probe of cognitive control and functional capacity that will become a universal screen for HIVCI. We propose three Phase 1 aims before pursuing a larger Phase II project: Aim 1: Develop a research production-grade version of VDCA incorporating new driving scenarios to task cognitive, sensorimotor and memory systems with associated metrics as guided by our complementary work with MEG; Aim 2: Conduct an observational pilot study by recruiting HIV+ patients from Drexel University’s established and NIMH-supported longitudinal cohort to test the hypothesis that VDCA performance can differentiate participants with and without HIVCI - thereby providing initial evidence to support the VDCA as a HIVCI screening solution; Aim 3: Assess the usability, feasibility and barriers of implementing the VDCA in a clinical setting by leveraging insights from the Aim 2 implementation team and from a comprehensive healthcare team providing HIV healthcare services in a limited-resource clinical setting. These insights will provide support for utility and feasibility of the VDCA as a universal screen and set the direction for future refinement, testing and evaluation in Phase II.