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

针对 HIV 相关中枢神经系统损伤的新型预筛查工具的初步验证：虚拟驾驶和中枢神经系统评估系统 (VDCA)

• 批准号: 10426510
• 负责人: Venkatesh Kandadai
• 金额: $ 5.49万
• 依托单位: DIAGNOSTIC DRIVING, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-07 至 2021-08-03
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10426510
• 关键词: Acquired Immunodeficiency Syndrome; Activities of Daily Living; Algorithms; Area; Automobile Driving; Clinic; Clinical; Clinical Treatment; Code; Comprehensive Health Care; Data; Delaware; Detection; Development; Diagnosis; Diagnostic tests; Disease; Early Diagnosis; Ensure; Evaluation; Face; Federally Qualified Health Center; Focus Groups; Future; Goals; Group Interviews; HIV; HIV diagnosis; Human Resources; Human immunodeficiency virus test; Impaired cognition; Impairment; Individual; Licensing; Link; Longitudinal cohort; Magnetoencephalography; Measures; Medical; Medical Care Team; Memory; Monitor; Motor; National Institute of Mental Health; Neurocognitive Deficit; Neuropathogenesis; Ohio; Online Systems; Outpatients; Participant; Patients; Performance; Phase; Pilot Projects; Production; Protocols documentation; Quality of life; Research; Research Priority; Resources; Risk; Safety; Screening procedure; Self-Direction; Sensitivity and Specificity; Short-Term Memory; Small Business Innovation Research Grant; Structure; System; Testing; Training; Universities; Validation; Work; base; clinical care; clinical decision support; cognitive control; cognitive task; cohort; cost; design; disability; driving safety; early screening; executive function; experience; functional disability; health care service; impaired driving performance; implementation cost; improved; innovation; insight; interest; member; neuroAIDS; neuroimaging; novel; phase 2 study; programs; recruit; screening; support tools; tool; usability; virtual

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.

项目概要和摘要 检测HIV相关CNS损害（HIVCI）的标准范例涉及以下方案， 需要训练有素的人员，这在典型的门诊临床环境中通常是不切实际和不可用的。因此，在本发明的一个方面， HIVCI通常未被发现或发现较晚，导致生活质量降低和生存率下降。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 目前，作为诊断测试的先驱， 目前正在进行中，但其能力和范围受到严重限制。因此，迫切需要使 这种新的模式可以在疾病过程的早期检测到HIVCI（NIMH部门感兴趣的主题领域 艾滋病研究和艾滋病毒神经发病机制计划）：普遍筛查（不需要受过培训的工作人员）， 可靠地将艾滋病毒阳性患者转介给神经心理测量（NP）诊断测试（由受过培训的工作人员进行）。该SBIR 提出了一种新的价值主张：一种基于已知功能的通用筛选工具， 驾驶障碍。因此，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、易于管理的通用筛查系统， 艾滋病毒阳性患者。为了实现这些目标并制定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 科学知识，利用驾驶任务的认知，感觉运动和记忆系统（包括那些 与HIV感染有关）;以及（3）我们独家访问已建立的HIV+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 有意义的探索认知控制和功能能力，将成为一个通用的屏幕艾滋病毒感染。我们 在进行更大的第二阶段项目之前，提出三个第一阶段目标：目标1：开展研究 VDCA的生产级版本，将新的驾驶场景纳入任务认知，感觉运动和 记忆系统与相关指标的指导下，我们的互补工作与MEG;目标2：进行 一项观察性试点研究，从德雷克塞尔大学建立的和NIMH支持的 纵向队列，以检验VDCA性能可以区分有和无VDCA的受试者的假设 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 目标2执行小组和提供艾滋病毒保健服务的综合保健小组 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 作为一个通用的屏幕，并确定了未来的改进，测试和评估在第二阶段的方向。