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.

项目摘要和摘要 检测与HIV相关的CNS损伤（HIVCI）的标准范式涉及协议 需要训练有素的人员，在典型的门诊临床环境中通常不切实际且不可用。因此， Hivci通常未被发现或迟到，导致生活质量较低并增加了生存。与 需要早期检测和新医疗计费代码的可用性，最近的推动 目前，范式旨在筛查认知障碍作为诊断测试的先驱 进行;但是，其能力和范围受到严重限制。因此，迫切需要启用 这种新的范式在疾病课程中早期检测HIVCI（NIMH部门感兴趣的主题领域 艾滋病研究和艾滋病毒神经病生成计划）：普遍筛查（不需要训练有素的员工） 可靠地将HIV+患者转介给神经心理测量（NP）诊断测试（受过训练的人员）。这个Sbir 提案一个新颖的价值提议：基于已知功能的通用筛选工具 障碍 - 驾驶。这是这个SBIR的长期目标是新的虚拟驾驶和CNS 评估系统（VDCA）作为有效的，低成本，易于管理的通用筛查系统 HIV+患者。为了实现这些目标并发展VDCA，我们将利用（1） 社会成功的虚拟驾驶测试（VDT）作为开发VDCA的平台； （2）我们的团队 科学的知识在使用开车来任务认知，感觉运动和记忆系统（包括 在hivci中实施）； （3）我们独家访问既定的艾滋病毒+参与者纵向队列； （4） 检测HIVCI发病机理的新型神经影像学方法。我们使用的初步工作 磁脑摄影（MEG）支持VDCA的发展，作为认知的有意义的探测 控制和功能能力将成为HIVCI的通用屏幕。在这项补充中，我们提出了 在追求父母SBIR奖中成功的成功工作之外，另一个目标是 较大的II期项目：目标1：进行可行性成像研究，以量化HIVCI的发病机理 通过VDCA性能衡量的额叶皮质的执行网络。这些见解将提供 支持VDCA作为通用屏幕的效用和可行性，并为未来设定方向 II期的细化，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