Optimizing Technology and Treatment for Non Specific Chronic Low Back Pain

非特异性慢性腰痛的优化技术和治疗

• 批准号: 9255114
• 负责人: Laura Dipietro
• 金额: $ 22.44万
• 依托单位: HIGHLAND INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255114
• 关键词: Acoustics; Address; Advisory Committees; Aftercare; Area; Back Pain; Beck depression inventory; Behavior; Biomechanics; Brain; Characteristics; Chronic low back pain; Clinical; Confidential Information; Coupling; Data; Data Set; Development; Disease; Dose; Double-Blind Method; Effectiveness; Electromagnetics; Electrophysiology (science); Esthesia; Gait; Head; Health Surveys; Intervention; Knee Osteoarthritis; Lead; Linear Regressions; Low Back Pain; Magnetic Resonance Imaging; Metabolic; Methods; Modality; Modeling; Motor Cortex; Neurologic; Outcome; Pain; Pain Research; Pain management; Patient-Focused Outcomes; Patients; Penetration; Perception; Phase; Physical Function; Posture; Procedures; Process; Psychosocial Assessment and Care; Research; Rights; SF-36; Safety; Self Assessment; Sensory; Site; Small Business Innovation Research Grant; Source; Stratification; Structure; System; Techniques; Technology; Testing; Therapeutic Effect; Tissues; Transcranial magnetic stimulation; Treatment Efficacy; Ultrasonics; United States; United States National Institutes of Health; Work; abstracting; base; behavioral study; chronic pain; commercialization; comparative efficacy; computer studies; disability; efficacy testing; human subject; improved; indexing; instrument; novel; patient stratification; prognostic; psychologic; psychosocial; randomized placebo controlled trial; relating to nervous system; research study; social; symptom treatment; technology development; treatment duration; vector

Proprietary: This proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of Health (NIH) for the sole purpose of evaluating this SBIR proposal. No other rights are conferred. This proposal and the trade secrets and other proprietary or confidential information contained herein shall further not be disclosed in whole or in parts, outside of NIH without Highland Instrument's permission. This restriction does not limit the NIH's right to use information contained in the data if it is obtained from another source without restriction. This legend applies to the entire proposal, including, but not limited to the Abstract, Introduction, Specific Aims, Research Plan (all components), Commercialization Plan, and Human Subject's Sections of this proposal. Abstract. Chronic low back pain (CLBP) is a leading cause of pain and disability[1-5]. Non-specific low back pain (i.e., without a known cause) is the most pervasive type of back pain [3]. Current therapies [4, 6-12] do not directly address the fact that pain sensation is processed in the brain [4, 6, 7] even though non-specific chronic low back pain (NSCLBP) symptomology can correlate with chronic pain induced changes in brain activity and/or structure [13-21]. Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of chronic pain [14, 15, 22]. However, the most common NIBS methods, Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), have shown limited, if any, efficacy in treating NSCLBP [23-28]. . It has been postulated that limitations in these techniques' focality, penetration, and targeting control limit their therapeutic efficacy [29-33]. 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. This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat NSCLBP. First in Phase I, to assess the feasibility of the proposed work, we will follow 20 NSCLBP patients after giving a fixed dose of ESStim for 10 days, 20 min/day, over a two-week period (10 SHAM ESStim, 10 ESStim). We will assess a battery of safety, pain, quantitative sensory testing (QST), function, and global psychosocial self-assessments in the patients, evaluated over the treatment period and for at least six weeks following the last treatment session. Next in Phase II, we will follow 40 NSCLBP patients (20 ESStim, 20 SHAM) after giving a fixed dose of stimulation for 10 days, 20 min/day, over a two-week period, followed by three weeks of bi-weekly stimulation, 20 min/day (16 total stimulations). We will evaluate these patients with the same 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. In parallel with the NSCLBP treatments, we will build MRI derived models of the stimulation fields in the heads (electric and acoustic field models) of the NSCLBP patients to calculate the stimulation field characteristics at the brain target sites. Multivariate linear and generalized linear regression models will then be built and evaluated to predict the NSCLBP patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics and the MRI based dosing models. The computational work will be combined to develop an optimized NSCLBP ESStim dosing model. Overall, we hypothesize that the proposed experiments, computational studies, and technology development will allow us to optimize ESStim for NSCLBP treatment.

专有：该提案包括高地工具的商业秘密和其他专有或机密信息，并正在美国国立卫生研究院（NIH）提供使用该SBIR提案的唯一目的。没有其他权利获得。这个建议和 未经高地仪器的许可，不得全部或部分披露本文包含的商业秘密以及其他专有或机密信息。该限制并不限制NIH使用数据中包含的信息的权利，如果它是从数据中获得的 另一个无限制的来源。该传说适用于整个建议，包括但不限于摘要，引言，特定目的，研究计划（所有组件），商业化计划以及人类主题的该提案部分。 抽象的。慢性腰痛（CLBP）是疼痛和残疾的主要原因[1-5]。非特异性的低背部 疼痛（即没有已知原因）是最普遍的背痛类型[3]。当前疗法[4，6-12]做 并不能直接解决大脑中疼痛感觉的事实[4，6，7] 慢性下腰痛（NSCLBP）症状可能与慢性疼痛引起的大脑变化有关 活动和/或结构[13-21]。非侵入性脑刺激（NIB）已成功应用于 在某些疾病状态下的慢性疼痛治疗，治疗诱导的脑活动变化恢复 与慢性疼痛的感知/感觉有关的适应性可塑性[14、15、22]。但是，最多 常见的NIBS方法，经颅磁刺激（TMS）和经颅直流电流刺激 （TDC），在治疗NSCLBP [23-28]中显示出有限的（如果有效）。 。有人认为限制 在这些技术的焦点，渗透和靶向控制中，限制了其治疗效率[29-33]。 电体刺激（ESSTIM™）是一种改进的笔尖模态，它克服了其他的局限性 通过将独立控制的电磁和超声波磁场相结合以聚焦和提升来提高技术 通过在神经组织中调谐机电耦合的刺激电流。该提议的重点是 评估我们的非侵入性埃斯蒂姆系统是否可以有效治疗NSCLBP。第一阶段，评估 提议的工作的可行性，我们将在给固定剂量的ESSTIM剂量后关注20名NSCLBP患者 10天，20分钟/天，在两个星期的时间内（10张埃斯蒂姆，10埃斯蒂姆）。我们将评估一个电池 安全，疼痛，定量感官测试（QST），功能和全球社会心理自我评估 患者在治疗期间进行评估，并在上次治疗后至少六周进行评估。 第二阶段，我们将关注40名NSCLBP患者（20个Esstim，20假）。 在两周的时间内刺激10天，20分钟/天，然后进行三周的每两周刺激， 20分钟/天（16个总刺激）。我们将通过相同的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。与NSCLBP处理并行，我们将建立 NSCLBP患者的头部（电场和声场模型）中的刺激场以计算 大脑目标部位的刺激场特征。多元线性和广义线性回归 然后将建立和评估模型，以预测与疼痛，身体相关的NSCLBP患者结果 功能和社会心理评估是基线疾病特征和基于MRI的功能 给药模型。计算工作将合并以开发优化的NSCLBP ESSTIM剂量 模型。总体而言，我们假设拟议的实验，计算研究和技术 开发将使我们能够优化NSCLBP治疗的ESSTIM。