Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

虚拟现实治疗幻腿痛的疗效及机制

• 批准号: 10297745
• 负责人: LAUREL J BUXBAUM
• 金额: $ 62.95万
• 依托单位: ALBERT EINSTEIN HEALTHCARE NETWORK
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10297745
• 关键词: Address; Adherence; Aftercare; Agreement; Algorithms; Amputation; Anxiety; Auditory; Behavioral; Biological Markers; Brain; Client satisfaction; Clinical; Consent; Data; Development; Dropout; Ensure; Equipment; Esthesia; Feedback; Feeling; Functional Magnetic Resonance Imaging; Functional disorder; Grant; Graph; Home; Human; Image; Individual; Intervention; Investigation; Knee; Laboratories; Leg; Limb structure; Lower Extremity; Magnetic Resonance Imaging; Measures; Mental Depression; Mental Health; Methods; Modification; Motion; Motor; Movement; Nature; Neuroanatomy; Neuronal Plasticity; Pain; Pain in lower limb; Pain management; Participant; Persons; Phantom Limb; Phantom Limb Pain; Pharmaceutical Preparations; Play; Prediction of Response to Therapy; Predictive Factor; Quality of life; Randomized; Research; Rest; Safety; Sampling; Sensory; Signal Transduction; Syndrome; System; Tactile; Target Populations; Testing; Time; Treatment Efficacy; Treatment Protocols; Treatment outcome; Upper Extremity; Vision; Visual; Work; arm; base; classification trees; clinical biomarkers; clinical implementation; comorbidity; comparative efficacy; control trial; cost; design; efficacious treatment; experience; falls; follow-up; head mounted display; imaging biomarker; imaging study; indexing; intense pain; limb amputation; limb loss; multimodality; neuroimaging marker; pain reduction; predicting response; predictive marker; programs; psychologic; regression trees; relating to nervous system; sensory feedback; telerehabilitation; translational pipeline; treatment optimization; treatment response; ultra high resolution; virtual; virtual reality; visual feedback

Project Summary Limb loss due to amputation is a common problem, occurring in nearly 2 million people in the US. Approximately 90% of individuals with limb amputation experience the persistent sensation of the missing extremity, known as a phantom limb, and up to 85% experience persistent and debilitating pain in the missing limb, termed phantom limb pain (hereafter PLP). We previously demonstrated that Virtual Reality (VR) with active leg movements and vision of a virtual limb significantly reduce phantom limb pain in subjects with below the knee amputations. The work proposed here has several objectives. In Specific Aim 1 we will randomize 40 subjects with PLP to treatment with our Active VR or a commercially available VR pain treatment (Cool!). In Specific Aim 2 we propose to develop a home intervention for PLP using the intervention (Active VR or Cool!) that in Specific Aim 1 proved to be most efficacious. In specific Aim 3 we will obtain multimodal ultra-high resolution (7T) MRI imaging in subjects with PLP before and after treatment, and normal subjects without amputation; we will also attempt to develop imaging biomarkers that predict efficacy of treatment. Imaging studies will address a number of controversies regarding the neural basis of PLP and explore human neuroplasticity more generally. Finally, in Specific Aim 4 we propose to determine factors that could be used in a clinical biomarker-based algorithm to predict response to home-based VR treatment. Using classification and regression tree (CART) analysis with the data from Aim 2, we will identify behavioral and neuroanatomic factors that predict treatment response. By the end of the grant period, we will have determined the relative efficacy of two VR treatments for PLP, assessed the feasibility and efficacy of a low-cost home-based treatment, determined the neuroanatomic changes associated with treatment response using advanced methods, and explored the behavioral and neuroimaging biomarkers predicting treatment response. These data will provide a critical step toward clinical implementation of a VR treatment protocol for PLP and will advance theoretical understanding of the mechanisms and functional neuroanatomy of PLP.

项目概要 截肢造成的肢体丧失是一个常见问题，在全世界有近 200 万人发生。 我们。大约 90% 的截肢患者都会经历持续的感觉 缺失的肢体，称为幻肢，高达 85% 的人会经历持续性和 缺失肢体的衰弱性疼痛，称为幻肢痛（以下简称 PLP）。我们之前 证明了虚拟现实（VR）具有主动腿部运动和虚拟肢体的视觉 显着减轻膝盖以下截肢患者的幻肢疼痛。工作 这里提出的建议有几个目标。在具体目标 1 中，我们将随机抽取 40 名具有 PLP 的受试者， 使用我们的 Active VR 或市售 VR 疼痛治疗进行治疗（酷！）。特定目标 2 我们建议使用以下干预措施（Active VR 或 Cool！）为 PLP 开发家庭干预措施： 具体目标 1 被证明是最有效的。在具体目标 3 中，我们将获得多模态超高 PLP 受试者治疗前后以及正常受试者的分辨率 (7T) MRI 成像 无需截肢；我们还将尝试开发预测疗效的成像生物标志物 治疗。影像学研究将解决有关 PLP 神经基础的许多争议 并更广泛地探索人类神经可塑性。最后，在具体目标 4 中，我们建议确定 可用于基于临床生物标记的算法来预测对家庭治疗的反应的因素 VR治疗。使用分类和回归树 (CART) 分析目标 2 的数据，我们 将识别预测治疗反应的行为和神经解剖学因素。到年底 资助期间，我们将确定两种 VR 治疗 PLP 的相对疗效，评估 低成本家庭治疗的可行性和有效性，确定了神经解剖学的变化 使用先进方法与治疗反应相关联，并探索了行为和 预测治疗反应的神经影像生物标志物。这些数据将提供关键的一步 致力于 PLP VR 治疗方案的临床实施，并将推进理论研究 了解 PLP 的机制和功能神经解剖学。