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: 10474765
• 负责人: Venkatesh Kandadai
• 金额: $ 7.4万
• 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: 2021-08-04 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10474765
• 关键词: Acquired Immunodeficiency Syndrome; Activities of Daily Living; Area; Automobile Driving; Award; Clinical; Code; Data; Detection; Development; Diagnosis; Diagnostic tests; Disease; Early Diagnosis; Etiology; Evaluation; Functional Magnetic Resonance Imaging; Future; Goals; HIV; HIV diagnosis; Human Resources; Human immunodeficiency virus test; Impaired cognition; Impairment; Individual; Link; Longitudinal cohort; Magnetoencephalography; Measures; Medical; Memory; Methods; Motor; National Institute of Mental Health; Neurocognitive Deficit; Neurologic; Neuropathogenesis; Outpatients; Parents; Participant; Pathogenesis; Patients; Performance; Persons; Phase; Procedures; Protocols documentation; Quality of life; Research; Research Domain Criteria; Research Priority; Resource-limited setting; Resources; Risk; Screening procedure; Small Business Innovation Research Grant; Standardization; System; Testing; Training; Validation; Work; base; cognitive control; cognitive system; cognitive task; cost; early screening; efficacy study; frontal lobe; functional disability; imaging study; impaired driving performance; improved; insight; interest; neuroAIDS; neuroimaging; novel; phase 2 study; programs; screening; sensorimotor system; 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); (3) our exclusive access to an established longitudinal cohort of HIV+ participants; and (4) novel neuroimaging methods to detect HIVCI pathogenesis. 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. In this supplement, we propose one additional aim building off of the successful work conducted in parent SBIR award, before pursuing a larger Phase II project: Aim 1: Conduct a feasibility imaging study to quantify HIVCI pathogenesis in the executive network of the frontal cortex as measured by VDCA performance. These insights will provide support for the 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 相关中枢神经系统损伤 (HIVCI) 的标准范例涉及以下协议： 需要经过培训的人员，但在典型的门诊临床环境中通常不切实际且无法获得。因此， HIVCI 通常未被发现或发现较晚，导致生活质量下降和生存率降低。随着 需要及早检测和提供新的医疗计费代码，最近推动改变 目前，早期筛查认知障碍作为诊断测试的先决条件的范例 进行;然而，其能力和范围受到严重限制。因此，迫切需要启用 这种在病程早期检测 HIVCI 的新模式（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（不需要经过培训的工作人员） 可靠地将 HIV+ 患者转介至神经心理测量 (NP) 诊断测试（由经过培训的工作人员进行）。这个SBIR 提出了一个新颖的价值主张：基于已知功能的通用筛选工具 障碍-驾驶。因此，本次 SBIR 的长期目标是建立新的虚拟驾驶和 CNS 评估系统 (VDCA) 作为一种有效、低成本、易于管理的通用筛选系统 HIV+患者。为了实现这些目标并发展 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（包括那些 涉及 HIVCI）； (3) 我们独家接触已建立的 HIV+ 参与者纵向队列；和（4） 检测 HIVCI 发病机制的新神经影像方法。我们的前期工作使用 脑磁图 (MEG) 支持 VDCA 作为一种有意义的认知探索的发展 控制和功能能力将成为 HIVCI 的通用筛查。在本补充中，我们建议 在追求 SBIR 奖项之前，还有一个目标是建立在 SBIR 奖项的成功工作之上 更大的第二阶段项目：目标 1：进行可行性成像研究以量化 HIVCI 发病机制 通过 VDCA 性能测量额叶皮层的执行网络。这些见解将提供 支持 VDCA 作为通用屏幕的实用性和可行性，并为未来设定方向 第二阶段的细化、测试和评估。

项目成果

Examining virtual driving test performance and its relationship to individuals with HIV-associated neurocognitive disorders.

• DOI: 10.3389/fnins.2022.912766
• 发表时间: 2022
• 期刊: FRONTIERS IN NEUROSCIENCE
• 影响因子: 4.3
• 作者: Grethlein, David;Pirrone, Vanessa;Devlin, Kathryn N.;Dampier, Will;Szep, Zsofia;Winston, Flaura K.;Ontanon, Santiago;Walshe, Elizabeth A.;Malone, Kim;Tillman, Shinika;Ances, Beau M.;Kandadai, Venk;Kolson, Dennis L.;Wigdahl, Brian
• 通讯作者: Wigdahl, Brian