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

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.

摘要 疼痛是各种伤害和疾病中最常见和最令人衰弱的症状之一。其 治疗通常依赖于处方或非处方药物， 非药物疼痛管理方法，如经皮神经电刺激（TENS） 或者针灸，这些都缺乏文献支持。医生通常反复探索这些 他们努力为每位患者确定最合适的方法。不幸的是， 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 阿片类药物过量处方和滥用的流行，具有危险的个人和社会后果。这 阿片类药物危机是公共卫生领域的一个主要问题，每年有47，000多人死亡， 在美国，每年的经济负担超过785亿美元。治疗疼痛的安全有效的替代品 因此，减少对阿片类药物的依赖是NIH的主要目标，迫切需要 解决这个紧急情况。 该项目提出了一种非侵入性，非药物替代治疗疼痛， 沉浸式虚拟现实中基于脑电图（EEG）创新神经反馈（NF）解决方案 (VR)环境NF和VR已被证明独立地产生对疼痛的改善作用，并且 假设VR中的NF训练会产生协同效应，因为VR会分散疼痛 感知，以提高患者在更具吸引力的NF方案中的依从性， 痛觉 这种NF+EEG+VR（NEVR）疼痛治疗系统结合了三种有前途的非药物创新 QUASAR的易于使用、无创、干电极EEG 头戴式耳机，无需凝胶或皮肤准备，即可快速轻松采集高保真EEG， 与2）用于认知沉浸的VR显示器集成，这已被证明可以分散和抑制 短期内的疼痛意识，两者都与3）已被证明可以降低cLBP的NF协议相关联 效果持续超过6个月。这种组合式NEVR疼痛治疗系统旨在 专门解决与感知或注意疼痛相关的潜在大脑活动， 因此，预计将减少急性和慢性疼痛。 在这个项目的范围内，我们将首先把我们的工作重点放在慢性腰痛（cLBP），因为这是一个 越来越多的慢性疼痛患者，全球终生患病率为39%， 在历史上，阿片剂使用者人数很多;但是，该项目的后期阶段将扩大这一范围， 用于治疗其他形式的疼痛。