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.

摘要 阿尔茨海默病（AD）和AD相关痴呆（ADRD）目前影响超过580万美国人， 到2020年将耗资3050亿美元，并导致诸如丧失独立性、生活质量低下等不良后果， 养老院的要求考虑到与健康相关的生活质量下降的规模， 可定制的脑靶向方法来帮助AD/ADRD患者势在必行。2019冠状病毒病疫情后 我们认为，越来越需要确定更有效的非侵入性数字化治疗方法， 认知障碍（CI）干预措施，很容易适应和远程访问的人的 回家 ClarityTek建议开发针对个性化衰老需求的虚拟现实认知疗法（VRCT）。 这种治疗将是结构化的，基于多学科证据，目标导向，多成分，远程 管理，并设计了一个广泛的范围。我们将创造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患者能够适应他们的新生活。 改善他们的生活质量。VRCT采用四管齐下的方法：评估，教育，治疗和跟踪。 AD的干预措施必须考虑认知缺陷的各个方面，特别是影响活动的认知技能 日常生活能力（ADL）和工具性ADL（IADL）。VR是沉浸式的，将患者与周围环境隔离开来 干扰对任何人工智能干预都至关重要VRCT培训活动泛化到真实的生活中，量身定制， 适应和挑战，将模拟现实的CI生产场景中发生的情况。在VRCT中， 通过游戏循环重复CI场景暴露将逐渐训练患者的实际技能， 日常情况：医疗预约，服用药物，购物，识别姓名和面孔，以及 到地方的方向。保留这些技能将提高功能独立性。VRCT干预的目的是 以矫正IADL特定残疾。它将包括一个可选的集成， 无需面对面接触的在线治疗师咨询，在COVID-19大流行期间非常重要。 VRCT阿尔茨海默氏症与CI跻身世界前5名的创新，在国际数字健康 竞争 在这个第一阶段的项目中，我们将与健康伙伴神经科学中心的阿尔茨海默氏症小组合作， 研究和实践专业知识，以领导试验，并帮助设计，开发和优化AD患者的VRCT。 我们将纳入利益相关者的反馈，以创建一个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。为了指导该项目，我们将 建立多学科专家焦点小组。 在目标1中，我们将评估VRCT的可行性、可用性、可接受性和36例患者的初步临床疗效。 轻度至中度CI的AD/ADRD患者超过7周。我们将进行三次试验，每次试验都有一个 队列n=12，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， 进行最有效的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。 专家焦点小组的试验和指导。我们希望建立VRCT将是可行的，可用的， 可用性量表的成功率为90%，用户满意度为80%，认知能力提高。