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（文本30行） 关节炎是成年人残疾的主要原因，今天影响了5400万美国人，据估计 到2040年，增长到7800万关节炎患者。关节炎是慢性使用者中最常见的慢性病 在美国，o opioids的占骨使用障碍社会的2000亿美元成本中的最大部分。 在关节炎的美国人中，有2500万人患有严重的关节疼痛。当前解决关节炎疼痛的方法， 例如阿片类药物，手术和物理疗法具有侵入性，昂贵，并带有相关风险，并且 不需要的不良副作用。那是有未满足的需要开发可以营救的替代疗法 对于具有数字，无药物，更永久，低风险，低成本的类似（或更好）效率的患者的关节疼痛， 可访问。 VRX Medical（VRX）计划通过虚拟现实（VR）体验利用其现有的成功 解决幻影肢体疼痛并完全开发新的基于智能手机的增强现实 （AR）医疗设备，诺丁汉。诺丁汉是一种使用增强现实（AR）的智能手机应用 缓解手，脚和膝盖的关节炎疼痛。诺丁汉将使顾客产生共同的痛苦 比其他可用的疗法以较低的成本和风险管理自己的状况，包括阿片类药物和其他 类似的添加止痛药。促交关节性疼痛的组成部分具有基于大脑的起源。因此，使用AR 更改大脑“看到”具有相同的皮质重组好处的镜子疗法（MT）和幻觉的益处 减少了复杂区域疼痛综合征1型（CRPS1）患者的疼痛。另外，像镜像疗法一样 诺丁汉已承诺可能影响大脑的皮质可塑性，从而产生长期的影响 持久的疼痛缓解。该阶段I项目将优化诺丁汉AR治疗的开发和 通过评估诺丁汉效率在概念证明可行性研究中通过36个诊断进行商业化。 骨关节炎患者。该研究旨在进一步研究潜在机制并验证 对疼痛和阿片类药物使用的有益影响。将比较有效数据和治疗前/治疗后的FMRI扫描 并进行了分析。第一阶段的完成将使VRX能够进行更大的II期临床研究，以提供 阿片类药物的替代性疼痛管理疗法。我们的最终目标是将诺丁汉带到最终用户，付款人， 雇主以及健康计划，并使用这部小说，基于AR的，避免阿片类药物的疼痛治疗来改善生活 关节炎患者患有关节疼痛。