Using Augmented Reality illusion therapy to develop a non-opioid chronic pain digital treatment

使用增强现实幻觉疗法开发非阿片类慢性疼痛数字治疗

• 批准号: 10541646
• 负责人: PAUL LAFFERTY
• 金额: $ 5.28万
• 依托单位: VRX MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-03-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10541646
• 关键词: Accounting; Address; Adult; Affect; Alternative Therapies; American; Analgesics; Arthralgia; Arthritis; Augmented Reality; Base of the Brain; Brain; Cellular Phone; Chronic; Clinical Research; Clinical Trials; Complex Regional Pain Syndromes; Data; Degenerative polyarthritis; Development; Diagnosis; Feasibility Studies; Goals; Hand; Hand Osteoarthritis; Illusions; Knee; Lead; Medical; Medical Device; Operative Surgical Procedures; Opioid; Pain; Pain management; Patients; Persistent pain; Phantom Limb Pain; Pharmaceutical Preparations; Phase; Physical therapy; Risk; Self Management; Societies; arthritic pain; base; chronic pain; chronic pain patient; commercialization; cost; design; digital; digital treatment; disability; experience; foot; functional MRI scan; health plan; improved; non-opioid analgesic; novel; opioid use; opioid use disorder; opioid user; pain reduction; pain relief; side effect; smartphone Application; success; therapy development; virtual reality

PROJECT SUMMARY/ABSTRACT (30 LINES OF TEXT) Arthritis is the leading cause of disability among adults, affecting 54 million Americans today and estimated to grow to 78 million arthritis sufferers by 2040. Arthritis is the most common chronic condition among chronic users of opioids in the US, accounting for the largest portion of the $200 billion cost to society of opioid use disorder. Of Americans with arthritis, 25 million live with severe joint pain. Current approaches to address arthritis pain, such as opioids, surgery, and physical therapies are invasive, expensive, and come with associated risks and unwanted adverse side effects. Thus, there is an unmet need to develop an alternative therapy that can relieve joint pain for patients with similar (or better) efficacy that is digital, drug-free, more permanent, low risk, low cost, and accessible. VRx Medical (VRx) plans to leverage its existing success with a Virtual Reality (VR) experience addressing Phantom Limb Pain and complete development of a new smartphone-based Augmented Reality (AR) medical device, Nottingham. Nottingham is a smartphone app that uses Augmented Reality (AR) to ameliorate arthritis pain in the hands, feet, and knees. Nottingham will enable customers with joint pain to self- manage their own condition at a lower cost and risk than other remedies available, including opioids and other similar addictive pain medications. A component of arthritic pain has brain-based origins; therefore, using AR to change what the brain “sees” has the same cortical reorganization benefits of Mirror Therapy (MT) and illusions that reduce pain in complex regional pain syndrome type 1 (CRPS1) patients. Also, like Mirror Therapy, Nottingham has promising potential to impact the cortical plasticity of the brain with effects that lead to long- lasting pain relief. This Phase I project will optimize the Nottingham AR therapy development and commercialization by evaluating Nottingham efficacy in a proof-of-concept feasibility study with 36 diagnosed osteoarthritis sufferers. The study is designed to further investigate the underlying mechanisms and validate the beneficial effects for pain and opioid use. Efficacy data and pre/post therapy fMRI scans will be compared for and analyzed. Completion of Phase I will enable VRx to perform a larger Phase II clinical study to provide an alternative pain management therapy to opioids. Our ultimate goal is to bring Nottingham to end-users, payers, employers, and health plans and use this novel, AR-based, opioid-avoiding pain treatment to improve the lives of arthritis patients suffering from joint pain.

项目概要/摘要（30 行文字） 关节炎是导致成年人残疾的主要原因，目前影响着 5400 万美国人，据估计 到 2040 年，关节炎患者将增至 7800 万。关节炎是慢性使用者中最常见的慢性病 在美国，阿片类药物使用障碍造成的社会损失高达 2000 亿美元，其中占比最大。 在患有关节炎的美国人中，有 2500 万人患有严重的关节疼痛。 例如阿片类药物、手术和物理疗法都是侵入性的、昂贵的，并且伴随着相关的风险和 因此，开发一种可以缓解不良副作用的替代疗法的需求尚未得到满足。 为关节疼痛患者提供类似（或更好）的疗效，即数字化、无药物、更持久、低风险、低成本、 VRx Medical (VRx) 计划通过虚拟现实 (VR) 体验充分利用其现有的成功。 解决幻肢痛并完成基于智能手机的新型增强现实的开发 (AR) 医疗设备，诺丁汉诺丁汉是一款使用增强现实 (AR) 的智能手机应用程序。 改善手、脚和膝盖的关节炎疼痛 诺丁汉将使患有关节疼痛的顾客能够自我治疗。 与其他可用的补救措施（包括阿片类药物和其他药物）相比，以更低的成本和风险来管理自己的病情 类似的成瘾性止痛药是关节炎疼痛的一个组成部分，因此，使用 AR 可以缓解疼痛。 改变大脑“看到”的东西与镜子疗法（MT）和错觉具有相同的皮质重组益处 减轻 1 型复杂区域疼痛综合征 (CRPS1) 患者的疼痛 此外，与镜子疗法一样， 诺丁汉具有影响大脑皮质可塑性的巨大潜力，其影响可导致长期 该第一阶段项目将优化诺丁汉 AR 疗法的开发和 通过在 36 名确诊患者的概念验证可行性研究中评估诺丁汉疗效，实现商业化 该研究旨在进一步研究潜在机制并验证。 将比较疗效数据和治疗前/治疗后功能磁共振成像扫描对疼痛和阿片类药物的有益影响。 第一阶段的完成将使 VRx 能够进行更大规模的第二阶段临床研究，以提供一个结果。 我们的最终目标是将诺丁汉带给最终用户、付款人、 雇主和健康计划，并使用这种新颖的、基于 AR 的、避免阿片类药物的疼痛治疗来改善生活 患有关节疼痛的关节炎患者。