Virtual Reality Cognitive Therapy forAlzheimer's Disease

阿尔茨海默病的虚拟现实认知疗法

• 批准号: 10385270
• 负责人: Razi Masood
• 金额: $ 44.53万
• 依托单位: CLARITYTEK, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385270
• 关键词: 3-Dimensional; Activities of Daily Living; Advocate; Affect; Aging; Alzheimer' s Disease; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Alzheimer' s disease therapy; American; Attention; Awareness; Brain; COVID-19; COVID-19 pandemic; COVID-19 pandemic effects; Caregivers; Code; Cognition; Cognitive; Cognitive Therapy; Cognitive deficits; Computer software; Consultations; Country; Cues; Dementia; Disease; Documentation; Economics; Effectiveness; Ensure; Equipment; Evaluation; Face; Family; Feedback; Focus Groups; Goals; Guidelines; Health; Home; Hospitals; Immersion; Impaired cognition; Impairment; Individual; International; Intervention; Lead; Life; Medical; Mental Depression; Methods; Names; Neural Pathways; Neuropsychology; Neurosciences; Nursing Homes; Occupational; Outcome; Participant; Pathway interactions; Patient Education; Patient Isolators; Patients; Persons; Pharmaceutical Preparations; Phase; Quality of life; Research; Resource-limited setting; Science; Slide; Social Distance; Societies; Speech; Structure; Summary Reports; System; Testing; Theoretical model; Therapeutic Intervention; Time; Training; Training Activity; Transferable Skills; Underserved Population; United States; Visual; base; clinical efficacy; cognitive function; cognitive rehabilitation; cognitive skill; cohort; cost; design; digital; digital health; digital treatment; disability; disability impact; distraction; experience; functional independence; health related quality of life; improved; innovation; instrumental activity of daily living; medical appointment; meetings; mindfulness; multidisciplinary; patient response; preservation; public health relevance; rehabilitation strategy; safe patient; satisfaction; skills; success; targeted treatment; telehealth; therapy development; tool; treatment response; usability; virtual reality; virtual reality game

Abstract Alzheimer’s disease (AD) and AD Related Dementias (ADRD) currently affect more than 5.8 million Americans, costing $305 billion in 2020 and causing poor outcomes such as loss of independence, low quality of life, and nursing home requirements. Given the scale of diminished health-related quality of life, the need for non-invasive customizable brain targeting methods to assist AD/ADRD patients is imperative. After the COVID-19 pandemic impact on AD patients, we believe there is a growing need for identifying more effective non-invasive digital Cognitive Impairment (CI) interventions that are easily adapted and remotely accessible within the person’s home. ClarityTek proposes to develop Virtual Reality Cognitive Therapy (VRCT) that targets individualized aging needs. This therapy will be structured, based on multidisciplinary evidence, goal-directed, multicomponent, remotely administered, and designed for a broad reach. We will create a tool to restore or reorganize neural pathways to compensate for impaired cognitive function and enable mild to moderate AD patients to adapt to their new situation and improve their QOL. VRCT utilizes a four-pronged approach: Assess, Educate, Treat, and Track. Interventions for AD must consider all facets of cognitive deficits, especially cognitive skills impacting activities of daily living (ADL) and instrumental ADL (IADL). VR is immersive, isolating the patient from surrounding distractions -- crucial for any CI intervention. VRCT training activities generalized to real life, tailored to engage, adapt, and challenge, will simulate realistic CI-producing scenarios in contexts where these occur. Within VRCT, repeated CI scenario exposure through game loops will gradually train the patients in practical skills to navigate everyday situations: medical appointments, taking medications, shopping, recognizing names and faces, and directions to places. Preserving these skills will improve functional independence. The VRCT intervention aims to remediate IADL specific disabilities. It will include an optional integration that makes possible asynchronous online therapist consultations without face-to-face contact, important during the COVID-19 pandemic. VRCT for Alzheimer’s with CI ranked among the world’s top 5 innovations in an international digital health competition. In this Phase I project, we will partner with groups at the HealthPartners Neuroscience Center with Alzheimer’s research and practice expertise to lead the trial and help design, develop, and optimize VRCT for AD patients. We will incorporate stakeholder feedback to create a patient-centric intervention targeting four specific prioritized CI related to IADL, utilizing the digital therapy development frameworks’ guidelines. To guide the project, we will create a multidisciplinary Expert Focus Group. In Aim 1, we will evaluate the feasibility, usability, acceptability, and the initial clinical efficacy of VRCT on 36 AD/ADRD patients with mild to moderate CI over seven weeks. We will conduct three trials, each trial with a cohort of n=12 total n=36 participants. Each trial’s results will be applied iteratively in Aim 2 to revise the VRCT, producing the most effective CI intervention. In Aim 2, we will iteratively redesign, develop, unit test, and optimize VRCT with the patients’ feedback from the trials and guidance from the Expert Focus Group. We expect to establish that VRCT will be feasible, usable, and acceptable with a Usability Scale success rate of 90%, user satisfaction of 80%, and improved cognition.

抽象的 阿尔茨海默病 (AD) 和 AD 相关痴呆症 (ADRD) 目前影响着超过 580 万美国人， 到 2020 年，其成本将达到 3050 亿美元，并造成不良后果，例如丧失独立性、生活质量低下、 鉴于健康相关生活质量下降的程度，需要非侵入性治疗。 COVID-19 大流行之后，帮助 AD/ADRD 患者的可定制大脑靶向方法势在必行。 由于对 AD 患者的影响，我们相信越来越需要确定更有效的非侵入性数字 认知障碍 (CI) 干预措施可在患者的认知范围内轻松调整并远程访问 家。 ClarityTek 建议开发针对个性化老龄化需求的虚拟现实认知疗法（VRCT）。 该疗法将基于多学科证据、目标导向、多成分、远程构建 我们将创建一种工具来恢复或重组神经通路。 补偿受损的认知功能，使轻度至中度 AD 患者能够适应新的环境 VRCT 采用四管齐下的方法：评估、教育、治疗和跟踪。 AD 干预措施必须考虑认知缺陷的所有方面，尤其是影响活动的认知技能 日常生活 (ADL) 和工具性 ADL (IADL) 是沉浸式的，将患者与周围环境隔离开来。 干扰——对于任何推广到现实生活的、专为参与而设计的 VRCT 干预活动都至关重要。 适应和挑战将在 VRCT 中模拟真实的 CI 生成场景。 通过游戏循环重复的 CI 场景暴露将逐渐训练患者的实际导航技能 日常情况：医疗预约、服药、购物、识别姓名和面孔，以及 保留这些技能将提高功能独立性。 修复 IADL 特定的缺陷 它将包括一个可选的集成，使异步成为可能。 无需面对面接触的在线治疗师咨询，这在 COVID-19 大流行期间很重要。 VRCT联合CI治疗阿尔茨海默病跻身国际数字健康领域全球5大创新之列 竞赛。 在这个第一阶段项目中，我们将与 HealthPartners 神经科学中心的阿尔茨海默病研究小组合作 研究和实践专业知识来领导试验并帮助设计、开发和优化 AD 患者的 VRCT。 我们将整合利益相关者的反馈，创建以患者为中心的干预措施，针对四个特定的优先事项 与 IADL 相关的 CI，利用数字治疗开发框架的指南来指导该项目。 创建一个多学科专家焦点小组。 在目标 1 中，我们将评估 VRCT 在 36 上的可行性、可用性、可接受性以及初步临床疗效。 患有轻度至中度 CI 的 AD/ADRD 患者将在七周内进行三项试验，每项试验都有一个试验。 n=12 的队列，总共 n=36 名参与者。每个试验的结果将在目标 2 中迭代应用，以修订 VRCT， 产生最有效的 CI 干预。 在目标 2 中，我们将根据患者的反馈迭代地重新设计、开发、单元测试和优化 VRCT 我们希望确定 VRCT 是可行的、可用的和专家焦点组的指导。 可用性量表成功率为 90%，用户满意度为 80%，认知能力得到改善，可以接受。