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

基本信息

批准号：
10706948
负责人：
Laura Dipietro
金额：
$ 74.55万
依托单位：
HIGHLAND INSTRUMENTS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-21 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10706948
关键词：
Address Affect American Applications Grants Boston Brain Carpal Tunnel Syndrome Characteristics Clinical Cognitive Coupled Coupling Development Dimensions Disease Dose Double-Blind Method 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 Population Process Psychosocial Assessment and Care Quality of life Questionnaires SF-36 Safety Self Assessment Sensory Site Structure System Techniques Technology Testing Tissues Transcranial magnetic stimulation Transducers Treatment Efficacy Ultrasonics United States Visit Work central pain chronic pain chronic pain management comparative efficacy diaries effectiveness testing efficacy testing improved neural noninvasive brain stimulation novel outcome prediction overtreatment pain reduction pain sensation pain symptom painful neuropathy randomized placebo controlled study safety assessment symptomatology transcranial direct current stimulation treatment duration treatment optimization

项目摘要

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.

腕管综合症 (CTS) 影响着多达 4% 的美国人口，其中工作人群的患病率更高慢性疼痛 (CP) 是 CTS 最常见且最难治疗的并发症之一 [2-6]。目前的疗法 [2-11] 并未直接解决疼痛感在大脑中处理的事实 [5, 12-14] 尽管 CTS 患者也有中枢性疼痛，但大多数作用于神经病变部位（即外周） CTS 症状与 CP 引起的大脑变化相关。活性和/或结构[14-24]已成功应用于非侵入性脑刺激（NIBS）。在某些疾病状态下治疗脑瘫，治疗引起的大脑活动变化会恢复适应不良与 CP 的感知/感觉相关的可塑性 [25-28] 然而，最常见的 NIBS 方法，例如，经颅直流电刺激在治疗神经性疼痛方面的疗效即使有的话也是有限的[13， 29-33]有人认为传统 NIBS 技术的聚焦性、穿透性和局限性。靶向控制限制了其治疗效果[34-38]。 NIBS 模式通过结合独立控制克服了其他技术的局限性电磁场和超声波场通过调谐机电来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 ESStim 系统是否有效。可以有效治疗 CTS 中的 CP，既可作为单独治疗，也可与物理治疗 (PT) 结合使用。第一阶段，评估拟议工作的可行性，并具体测试 ESStim 改进 CTS 的能力疼痛，我们将跟踪 20 名 CTS 患者，连续 5 天、20 分钟/天（10 SHAM ESStim，10 ESStim）我们将进行一系列安全、疼痛、定量感官测试（QST），在治疗期间至少评估运动功能和整体自我评估（例如生活质量）最后一次治疗后六周，我们将评估 ESStim 是否会引起疼痛。减少可以与物理治疗（PT）相结合来改善CTS治疗，我们将遵循60 CTS。患者（30 名 ESStim，30 名 SHAM）在两周内给予固定剂量刺激 10 天，每天 20 分钟，但现在与 PT 一起提供，我们将通过一系列评估来评估这些患者。在第一阶段进行验证，并比较测试干预措施在实施后至少八周内的效果我们勇敢地说 ESStim 可以与 PT 协同提供，因为两者都可以。鼓励可塑性相关的改变，从而最大限度地改善 CTS 患者的无痛活动能力。与 CTS 治疗并行，我们将建立多元线性和广义线性回归模型预测与疼痛、身体功能和社会心理评估相关的 CTS 患者结果计算工作将用于开发优化的 CTS。 ESStim 剂量模型。总体而言，我们努力开发用于 CTS 治疗的 ESStim™。