Enhancing Physical Therapy: Noninvasive Brain Stimulation System for Treating Carpal Tunnel Syndrome

加强物理治疗：无创脑刺激系统治疗腕管综合症

• 批准号: 9908734
• 负责人: Laura Dipietro
• 金额: $ 22.46万
• 依托单位: HIGHLAND INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-18 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9908734
• 关键词: Address; Affect; American; Applications Grants; Authorization documentation; Boston; Brain; Carpal Tunnel Syndrome; Characteristics; Clinical; Cognitive; Confidential Information; Coupled; Coupling; Data; Development; Disease; Dose; Double-Blind Method; Effectiveness; Electromagnetics; Electrophysiology (science); Equipment and supply inventories; Esthesia; Foundations; Hand; Health Surveys; High Prevalence; Injury; Intervention; Linear Regressions; Methods; Michigan; Modality; Modeling; Motor; Motor Cortex; Neurologic; Neuropathy; Outcome; Pain; Pain-Free; Patient-Focused Outcomes; Patients; Penetration; Perception; Phase; Physical Function; Physical therapy; Placebos; Population; Process; Psychosocial Assessment and Care; Quality of life; Questionnaires; Randomized; Research; Rights; SF-36; Safety; Self Assessment; Sensory; Site; Small Business Innovation Research Grant; Source; Structure; System; Techniques; Technology; Testing; Tissues; Transcranial magnetic stimulation; Transducers; Treatment Efficacy; Ultrasonics; United States; United States National Institutes of Health; Visit; Work; central pain; chronic pain; commercialization; comparative efficacy; diaries; efficacy testing; human subject; improved; instrument; novel; outcome prediction; overtreatment; pain reduction; pain sensation; pain symptom; painful neuropathy; relating to nervous system; safety assessment; symptomatology; treatment duration; treatment optimization

Carpal Tunnel Syndrome (CTS) affects up to 4% of the US population, with higher prevalence in the working population [1, 2]. Chronic pain (CP) is one of the most common and difficult to treat complications of CTS [2-6]. Current therapies [2-11] do not directly address the fact that pain sensation is processed in the brain [5, 12-14] and most act at the neuropathy site (i.e., in the periphery), although CTS patients also have a central pain component due to their injury [5, 6, 12-15]. CTS symptomatology correlates with CP-induced changes in brain activity and/or structure [14-24]. Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of CP in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain [13, 29-33]. It has been postulated that limitations in conventional NIBS techniques’ focality, penetration, and targeting control limit their therapeutic efficacy [34-38]. Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue [39]. This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in CTS, both as a lone treatment and in conjunction with physical therapy (PT). In Phase I, to assess the feasibility of the proposed work, and specifically test ESStim’s ability to improve CTS pain, we will follow 20 CTS patients after giving a fixed dose of ESStim for 5 consecutive days, 20 min/day (10 SHAM ESStim, 10 ESStim). We will administer a battery of safety, pain, quantitative sensory testing (QST), motor function, and global self-assessments (e.g., QOL) evaluated over the treatment period and for at least six weeks following the last treatment session. Next in Phase II, we will assess whether ESStim induced pain reductions can be coupled with physical therapy (PT) to improve CTS treatment. We will follow 60 CTS patients (30 ESStim, 30 SHAM) after giving a fixed dose of stimulation for 10 days over two weeks, 20 min/day, but now provided in conjunction with PT. We will evaluate these patients with the battery of assessments validated in Phase I, and compare the efficacy of the tested interventions for at least eight weeks following the last treatment session. We hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patient’s pain free mobility. In parallel with the CTS treatments, we will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model. Overall, we hypothesize that we will be able to develop ESStim™ for CTS treatment.

腕管综合征（CTS）影响多达4％的美国人口，工作率更高 人口[1，2]。慢性疼痛（CP）是最常见且难以治疗CTS并发症的一种[2-6]。 当前的疗法[2-11]不能直接解决大脑中疼痛感觉的事实[5，12-14] 尽管CTS患者也有中心疼痛 由于其受伤而导致的组成部分[5，6，12-15]。 CTS症状与CP诱导的大脑变化有关 活动和/或结构[14-24]。非侵入性脑刺激（NIB）已成功应用于 在某些疾病状态下CP的治疗，治疗诱导的脑活动变化恢复了适应不良 与CP的感知/感觉相关的可塑性[25-28]。但是，最常见的笔尖方法， 例如，thrancranial Direct电流模拟，显示有限（如果有的话）在治疗神经性疼痛方面有限[13， 29-33]。据推测，常规NIBS技术的焦点，渗透和 靶向控制限制了其治疗效率[34-38]。电刺激（ESSTIM™）是改进的 NIBS模式通过组合独立控制来克服其他技术的局限性 电磁场和超声波场，通过调谐机电聚焦和增强刺激电流 神经组织中的耦合[39]。该提案的重点是评估我们的无创性系统是否 可以有效地治疗CT中的CP，无论是一种孤独的治疗，还是与物理疗法（PT）结合使用。 第一阶段，评估拟议工作的可行性，并特别测试ESSTIM提高CTS的能力 疼痛，我们将连续5天（20分钟）给予20个CTS患者（10分钟） Sham Esstim，10 Esstim）。我们将管理一系列安全，疼痛，定量感觉测试（QST）， 运动功能和全球自我评估（例如，QOL）在治疗期间进行了评估，至少在 上一次治疗后六个星期。第二阶段的接下来，我们将评估Esstim是否引起疼痛 减少可以与物理疗法（PT）结合起来，以改善CTS治疗。我们将关注60 CTS 在两周，20分钟/天给予固定剂量刺激后，患者（30埃斯蒂姆，30假）， 但是现在与PT一起提供。我们将用一系列评估来评估这些患者 在第一阶段进行了验证，并比较了在 上次治疗。我们假设可以通过PT协同提供esstim，因为这两者都可以 鼓励依赖可塑性的变化，这可以最大程度地改善CTS患者的无疼痛活动性。在 与CTS处理并行，我们将建立多元线性和广义线性回归模型 预测与疼痛，身体机能和社会心理评估有关的CTS患者结果 基线疾病特征的功能。计算工作将用于开发优化的CTS Esstim剂量模型。总体而言，我们假设我们将能够开发用于CTS治疗的ESSTIM™。