Noninvasive Assessment of Neuromuscular Disease using Electrical Impedance

使用电阻抗对神经肌肉疾病进行无创评估

• 批准号: 8650344
• 负责人: Jose Luis Bohorquez
• 金额: $ 53.62万
• 依托单位: MYOLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8650344
• 关键词: Amyotrophic Lateral Sclerosis; Area; Biological Markers; Biopsy; Businesses; Carpal Tunnel Syndrome; Clinical; Clinical Trials; Collaborations; Cross-Sectional Studies; Data; Data Analyses; Device Designs; Devices; Diagnosis; Diagnostic; Discrimination; Disease; Disease Progression; Early Diagnosis; Electrodes; Electromyography; Electronics; Entrapment Neuropathies; Frequencies; Future; Genetic; Goals; Grant; Individual; Limb structure; Longitudinal Studies; Machine Learning; Manuals; Marketing; Measurement; Measures; Medical Device; Medical center; Methods; Monitor; Motor; Motor Neurons; Muscle; Muscle Fibers; Muscular Dystrophies; Myography; Nature; Needles; Neurologist; Neuromuscular Diseases; Neuropathy; Outcome; Painless; Patient Care; Patients; Phase; Physicians; Polyneuropathy; Polyradiculopathy; Procedures; Radiculopathy; Recruitment Activity; Relative (related person); Reproducibility; Research; Sensitivity and Specificity; Site; Small Business Innovation Research Grant; Speed; Spirometry; Symptoms; Syndrome; System; Techniques; Technology; Testing; Therapeutic Clinical Trial; Time; United States; Widespread Disease; Work; base; clinical care; commercial application; data acquisition; design; diagnosis design; disease diagnosis; drug testing; electric impedance; improved; indexing; innovation; muscle strength; muscular structure; neuromuscular; novel diagnostics; programs; prototype; pulmonary function; tool; validation studies

DESCRIPTION (provided by applicant): The neuromuscular disorders include a wide group of conditions ranging from relatively mild focal problems, such as carpal tunnel syndrome, to severe, generalized diseases, such as amyotrophic lateral sclerosis (ALS). Current methods for evaluating these disorders remain limited to a variety of tests and procedures that are either invasive or remarkably qualitative in nature. One newer technique, electrical impedance myography (EIM), offers the prospect of obtaining quantitative data on muscle condition painlessly and non-invasively. However, no commercial devices specifically tailored for EIM use exist, with nearly all previous EIM work relying upon off-the-shelf bioimpedance devices designed for "whole-body" rather than single-muscle assessment. In Phase 1 of this SBIR, Convergence Medical Devices, Inc (CMD) developed an initial prototype system to test proof-of-principle innovative concepts in circuit design and data acquisition to provide highly sensitive and accurate data at an extended frequency range (out to 10 MHz) and over multiple angles relative to the major muscle fiber direction. This work was followed by supplemental work that produced the first hand-held device with robust electronics capable of similar measurements with a detachable, interchangeable electrode array. In this 3-year Phase 2 SBIR, CMD proposes to further refine that technology so as to assist in disease diagnosis and for following disease progression, with a specific focus on amyotrophic lateral sclerosis. In Aim 1 of the proposed grant, testing of multiple electrode array designs will be performed on a group of normal subjects and those with ALS to determine which electrode array designs offer the greatest reproducibility and ability to discriminate healthy from diseased individuals. In Aim 2, the device and the 3 "best" array designs identified in Aim 1 will be tested in 30 ALS patients, 30 patients with syndromes mimicking ALS (e.g., polyradiculopathy and motor-predominant neuropathy), and 30 subjects with suspected/possible ALS to determine the single best array design for diagnosis and to determine its sensitivity and specificity. This study will take place at CMD and four external sites and will be managed by the Northeast ALS trials Consortium (NEALS), the premier organization for overseeing clinical trials in ALS. In Aim 3, the 30 suspected/possible ALS patients recruited in SA2 and 30 additional suspected/possible ALS patients will be assessed monthly using EIM and the 3 arrays identified in SA1. All subjects will also undergo standard measurements of disease progression including handheld dynamometry, ALS Functional Rating Scale, and spirometry. The best array design for assessing disease progression will be identified and compared to conventional markers of disease progression to determine EIM's sensitivity to disease status. Thus, at the conclusion of this research program, we anticipate having developed and vigorously tested an EIM device and associated electrode designs that together will serve as a powerful new diagnostic and monitoring tool for neuromuscular disease.

描述（由申请人提供）：神经肌肉疾病包括多种病症，从相对轻微的局灶性问题（例如腕管综合症）到严重的全身性疾病（例如肌萎缩侧索硬化症（ALS））。目前评估这些疾病的方法仍然局限于各种侵入性或本质上非常定性的测试和程序。电阻抗肌动描记术 (EIM) 是一种较新的技术，它提供了无痛、无创地获取肌肉状况定量数据的前景。然而，目前还没有专门为 EIM 使用而定制的商业设备，几乎所有以前的 EIM 工作都依赖于为“全身”而不是单肌肉评估而设计的现成生物阻抗设备。在此 SBIR 的第一阶段，Convergence Medical Devices, Inc (CMD) 开发了一个初始原型系统，用于测试电路设计和数据采集中的原理验证创新概念，以在扩展的频率范围（超出10 MHz）以及相对于主要肌纤维方向的多个角度。这项工作之后进行了补充工作，生产出了第一款具有强大电子设备的手持设备，能够通过可拆卸、可互换的电极阵列进行类似的测量。在这个为期 3 年的 2 期 SBIR 中，CMD 建议进一步完善该技术，以协助疾病诊断和跟踪疾病进展，特别关注肌萎缩侧索硬化症。在拟议拨款的目标 1 中，将对一组正常受试者和患有 ALS 的受试者进行多种电极阵列设计的测试，以确定哪种电极阵列设计提供最大的可重复性和区分健康个体和患病个体的能力。在目标 2 中，该装置 目标 1 中确定的 3 种“最佳”阵列设计将在 30 名 ALS 患者、30 名患有类似 ALS 综合征的患者（例如多发性神经根病和运动主导神经病）以及 30 名疑似/可能患有 ALS 的受试者中进行测试，以确定单一最佳方案用于诊断的阵列设计并确定其敏感性和特异性。这项研究将在 CMD 和四个外部地点进行，并由东北 ALS 试验联盟 (NEALS) 管理，该联盟是监督 ALS 临床试验的首要组织。在目标 3 中，SA2 中招募的 30 名疑似/可能的 ALS 患者和另外 30 名疑似/可能的 ALS 患者将每月使用 EIM 和 SA1 中确定的 3 个阵列进行评估。所有受试者还将接受疾病进展的标准测量，包括手持式测力计、ALS 功能评定量表和肺量计。将确定用于评估疾病进展的最佳阵列设计，并将其与疾病进展的常规标记物进行比较，以确定 EIM 对疾病状态的敏感性。因此，在本研究计划结束时，我们预计已经开发并积极测试了 EIM 设备和相关电极设计，它们将共同成为神经肌肉疾病的强大的新型诊断和监测工具。