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.

项目摘要/摘要(30行文本) 关节炎是成年人致残的主要原因，目前影响着5400万美国人，据估计 到2040年，关节炎患者将增长到7800万。关节炎是慢性使用者中最常见的慢性疾病 在阿片类药物使用障碍给社会造成的2000亿美元成本中，占最大部分。 在患有关节炎的美国人中，有2500万人患有严重的关节疼痛。目前解决关节炎疼痛的方法， 如阿片类药物、手术和物理疗法是侵入性的、昂贵的，并伴随着相关的风险和 不想要的副作用。因此，有一种尚未得到满足的需求，即开发一种替代疗法，可以缓解 关节疼痛的患者具有类似(或更好)的疗效，即数字化、免药物、更持久、低风险、低成本、 而且容易接近。VRX医疗公司(VRX)计划通过虚拟现实(VR)体验利用其现有的成功 解决幻肢疼痛并完全开发基于智能手机的新增强现实 (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。诺丁汉将使关节疼痛的客户能够自我 以比阿片类药物和其他可用药物更低的成本和风险管理自己的病情 类似的上瘾止痛药。关节炎疼痛的一个组成部分源于大脑；因此，使用AR来 改变大脑所看到的东西与镜像疗法(MT)和错觉具有相同的皮质重组益处 可减轻复杂区域疼痛综合征1型(CRPS1)患者的疼痛。此外，就像镜面疗法一样， 诺丁汉有希望通过影响大脑皮质的可塑性而导致长时间的- 持久的止痛药。这个第一阶段的项目将优化诺丁汉AR治疗的开发和 在一项概念验证可行性研究中评估诺丁汉疗效的商业化，共36例 骨关节炎患者。这项研究旨在进一步调查潜在的机制并验证 对疼痛和阿片类药物的使用有好处。疗效数据和治疗前/治疗后的fMRI扫描将进行比较 并进行了分析。第一阶段的完成将使VRX能够进行更大的第二阶段临床研究，以提供 替代阿片类药物的疼痛管理疗法。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。