Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy

用于非阿片类药物疼痛治疗的神经反馈-EEG-VR (NEVR) 系统

• 批准号: 9912651
• 负责人: Walid Soussou
• 金额: $ 22.49万
• 依托单位: QUASAR, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9912651
• 关键词: Acupuncture Therapy; Acute; Address; Attention; Awareness; Back; Brain; Cessation of life; Chronic; Chronic low back pain; Clinical; Clinical Trials; Cognitive; Computer software; Conduct Clinical Trials; Dangerousness; Data; Dependence; Devices; Disease; Double-Blind Method; Economic Burden; Effectiveness; Electrodes; Electroencephalography; Emergency Situation; Environment; FDA approved; Family; Feedback; Gel; Goals; Home environment; Hour; Immersion Investigative Technique; Injury; Lead; Literature; Location; Measures; Methods; Modality; Operative Surgical Procedures; Opioid; Outcome; Outcome Measure; Output; Pain; Pain Management Method; Pain management; Patients; Perception; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Physicians; Population; Preparation; Prevalence; Protocols documentation; Psychological reinforcement; Public Health; Randomized; Resolution; Signal Transduction; Skin; Surveys; Syndrome; System; Testing; Time; Training; Transcutaneous Electric Nerve Stimulation; United States National Institutes of Health; Work; addiction; base; chronic pain; common symptom; compliance behavior; cost; density; design; disabling symptom; falls; improved; innovation; innovative technologies; movie; neurofeedback; non-opioid analgesic; operation; opioid abuse; opioid epidemic; opioid use; pain perception; pain reduction; phase 1 study; phase 2 designs; prototype; recruit; sensor; social; sound; virtual reality; Acupuncture Therapy; Acute; Address; Attention; Awareness; Back; Brain; Cessation of life; Chronic; Chronic low back pain; Clinical; Clinical Trials; Cognitive; Computer software; Conduct Clinical Trials; Dangerousness; Data; Dependence; Devices; Disease; Double-Blind Method; Economic Burden; Effectiveness; Electrodes; Electroencephalography; Emergency Situation; Environment; FDA approved; Family; Feedback; Gel; Goals; Home environment; Hour; Immersion Investigative Technique; Injury; Lead; Literature; Location; Measures; Methods; Modality; Operative Surgical Procedures; Opioid; Outcome; Outcome Measure; Output; Pain; Pain Management Method; Pain management; Patients; Perception; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Physicians; Population; Preparation; Prevalence; Protocols documentation; Psychological reinforcement; Public Health; Randomized; Resolution; Signal Transduction; Skin; Surveys; Syndrome; System; Testing; Time; Training; Transcutaneous Electric Nerve Stimulation; United States National Institutes of Health; Work; addiction; base; chronic pain; common symptom; compliance behavior; cost; density; design; disabling symptom; falls; improved; innovation; innovative technologies; movie; neurofeedback; non-opioid analgesic; operation; opioid abuse; opioid epidemic; opioid use; pain perception; pain reduction; phase 1 study; phase 2 designs; prototype; recruit; sensor; social; sound; virtual reality

Abstract Pain is one of the most common and debilitating symptoms of a wide range of injuries and diseases. Its treatment often relies on prescription or over-the-counter pharmaceutical medications and may include some non-pharmacological pain management methods such as transcutaneous electrical nerve stimulation (TENS) or acupuncture, which have poor support from the literature. Physicians typically iteratively explore these options as they strive to identify the most suitable methods for each patient. Unfortunately, one of the most commonly prescribed pain treatments, opioids, has a potential to lead to addiction, which has led to an epidemic of opioid over-prescription and abuse, with dangerous personal and societal consequences. This opioid crisis is a principal issue in public health with over 47,000 related annual deaths, as well as social and economic burden costing over $78.5 billion a year in the USA. Safe and effective alternatives for treating pain that reduce dependence on opioids are, therefore, a primary goal of the NIH, and are urgently needed to address this emergency. This project proposes a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback (NF) solution in an immersive virtual reality (VR) environment. NF and VR have been shown to independently produce ameliorative effects on pain, and it is hypothesized that a NF training in VR would have synergistic effects as VR would distract from pain perception to improve patient compliance in more engaging NF protocols that improve their ability to control pain perception. This NF+EEG+VR (NEVR) pain treatment system combines three promising non-pharmacological innovative technologies into a non-invasive pain therapy: 1) QUASAR's easy-to-use, non-invasive, dry electrode EEG headset, which enables rapid and easy acquisition of high fidelity EEG without the gels or skin preparation, integrated with 2) a VR display for cognitive immersion, which has been shown to distract from and suppress pain awareness in the short-term, both interfacing with 3) a NF protocol that has been shown to reduce cLBP with effects lasting greater than 6 months. This combined NEVR pain treatment system is designed to specifically address the underlying brain activity associated with perception of, or attention to, pain and is therefore expected to reduce both acute and chronic forms of pain. In the scope of this project, we will initially focus our work on chronic low back pain (cLBP) as this is a growing segment of chronic pain sufferers with a 39% worldwide lifetime prevalence, and whose sufferers have historically been a heavy user population of opiates; however, later stages of this project will expand this application to address other forms of pain.

抽象的 疼痛是多种伤害和疾病的最常见和令人衰弱的症状之一。它是 治疗通常取决于处方或非处方药药物，可能包括一些 非药理疼痛管理方法，例如经皮神经刺激（TENS） 或针灸，文献的支持很差。医师通常迭代地探索这些 选择时，他们努力确定每个患者的最合适方法。不幸的是，其中之一 通常处方的疼痛治疗，阿片类药物有可能导致成瘾，这导致了 阿片类药物过度的处方和虐待的流行，带来了危险的个人和社会后果。这 阿片类药物危机是公共卫生中的主要问题，有超过47,000例相关的年死亡以及社会和 在美国，经济负担每年耗资超过785亿美元。安全有效治疗疼痛的替代方案 因此，减少对阿片类药物的依赖是NIH的主要目标，并且迫切需要 解决此紧急情况。 该项目提出了一种非侵入性的非药理学替代方法，以通过结合治疗疼痛 沉浸式虚拟现实中基于创新的脑电图（EEG）基于神经反馈（NF）解决方案 （VR）环境。 NF和VR已显示出对疼痛的独立改善作用，并且 假设VR中的NF培训会具有协同作用，因为VR会分散疼痛的注意力 在更吸引人的NF方案中提高患者遵守的看法，以提高其控制能力 疼痛感。 此NF+EEG+VR（NEVR）疼痛处理系统结合了三个有希望的非药理学创新 技术进入非侵入性疼痛疗法：1）类星体易于使用的，无创的，干电极EEG 耳机，可以快速轻松地获取高保真脑电图，而无需凝胶或皮肤制备， 与2）集成了一个用于认知浸入的VR显示器，已证明会分散注意力并抑制 短期内的疼痛意识，两者都与3）NF方案相连 效果持续超过6个月。这种组合的NEVR疼痛治疗系统设计为 特别解决与对疼痛或关注疼痛的感知相关的潜在大脑活动，并且 因此，有望减少急性和慢性疼痛。 在该项目的范围内，我们最初将把工作重点放在慢性腰痛（CLBP）上，因为这是一个 越来越多的慢性疼痛患者全球终身患病率为39％，其患者患有 从历史上看，鸦片的用户人数很高；但是，该项目的后期阶段将扩大 应用于解决其他形式的疼痛。