Noninvasive assessment of neuromuscular diseases using electrical impedance

使用电阻抗对神经肌肉疾病进行无创评估

• 批准号: 7907524
• 负责人: Jose Luis Bohorquez
• 金额: $ 22.06万
• 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 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7907524
• 关键词: Address; Adhesives; Affect; Amyotrophic Lateral Sclerosis; Anatomy; Anisotropy; Area; Businesses; Cattle; Child; Clinical; Clinical Trials; Collaborations; Complex; Data; Data Quality; Development; Devices; Diagnosis; Diagnostic; Disease; Disease Progression; Disease remission; Electrodes; Electromyography; Electronics; Employment; Engineering; Face; Fatty acid glycerol esters; Frequencies; Functional disorder; Funding; Goals; Grant; Health; Human; Hydration status; Lateral; Lead; Legal patent; Life; Measurement; Measures; Mechanics; Medical Device; Methods; Muscle; Muscular Dystrophies; Myography; Myopathy; Myositis; Needles; Nerve; Neuromuscular Diseases; Outcome Measure; Pain; Patient Care; Patients; Pattern; Pharmaceutical Preparations; Phase; Positioning Attribute; Procedures; Radiculopathy; Relative (related person); Research Personnel; Small Business Innovation Research Grant; Specific qualifier value; Structure; Surface; System; Techniques; Technology; Tern; Testing; Time; Widespread Disease; Width; Work; base; clinical decision-making; commercialization; compliance behavior; design; disease diagnosis; electric impedance; human subject; improved; interest; medical schools; nerve injury; neuromuscular; new technology; novel; prototype; public health relevance; sensor; subcutaneous; tool; voltage

DESCRIPTION (provided by applicant): Neuromuscular disorders, ranging from severe generalized diseases such as muscular dystrophy and amyotrophic lateral sclerosis (ALS) to localized conditions, including nerve injuries and radiculopathy, impact the lives of millions of people in the US and around the world. Today, diagnostic tools and general outcome measures remain largely qualitative and imprecise. Moreover, the frequently used invasive technique of needle electromyography is not only subjective, but is also painful and generally poorly tolerated. Furthermore, these diagnostic tools often require considerable patient cooperation, which can also lead to variability in data quality, especially when children are being tested. The lack of an accurate, noninvasive technology not only affects the diagnosis and treatment of patients, it also limits the ability to gauge the efficacy of new treatments during clinical trials. Thus, a technology that can rapidly, quantitatively, reliably, and noninvasively evaluate neuromuscular disease status with minimal patient cooperation, would find wide application not only as a diagnostic tool, but also as a means of tailoring patient care after diagnosis and for streamlining clinical drug trials. One technology that has shown great promise in this regard is electrical impedance myography (EIM). Over the past decade, EIM techniques have been studied extensively in human subjects in a variety of neuro- muscular disorders, and these studies have provided very promising results, including demonstrating that these techniques cannot only differentiate diseases from one another but also can assist in accurately assessing disease progression or remission over time. Almost all of these studies, however, have been made with commercially available impedance devices that are not optimized specifically for muscle health assessment. Thus, the goal of this Phase I SBIR application is to fund the initial development and testing of such a device, including the employment of novel mechanical sensor techniques and electronics to achieve better accuracy over a wider frequency range than possible with off-the-shelf systems. The specific aims of this project thus are: 1) to develop a set of robust, reconfigurable mechanical sensors that can interface with a variety of commercial impedance measurement devices; 2) to develop an electronic impedance-measuring system with novel circuit topology, specifically optimized for fast, accurate, and wide-bandwidth EIM measurements; and 3) to evaluate the developed system in a variety of test media. With the successful completion of these three aims, we will be well-positioned to test this device in clinical trials as part of a planned Phase II SBIR grant. PUBLIC HEALTH RELEVANCE: Neuromuscular disorders impact the lives of millions of people in the US and abroad. Diagnostic tools used for assessing muscle and nerve dysfunction remain largely qualitative, inaccurate, and painful, and are particularly difficult to use with children. The technique of electrical impedance myography (EIM) has shown great promise in overcoming these limitations. Thus, the overall goal of this project is to develop a handheld, noninvasive electrical impedance device that can perform accurate, rapid assessments of muscle health.

描述（由申请人提供）：神经肌肉疾病，从严重的全身性疾病（如肌营养不良症和肌萎缩侧索硬化症 (ALS)）到局部疾病（包括神经损伤和神经根病），影响着美国和世界各地数百万人的生活。如今，诊断工具和一般结果指标在很大程度上仍然是定性的且不精确。此外，经常使用的侵入性针肌电图技术不仅主观性强，而且痛苦且耐受性差。此外，这些诊断工具通常需要大量患者合作，这也可能导致数据质量的变化，尤其是在儿童接受测试时。缺乏准确、无创的技术不仅影响患者的诊断和治疗，还限制了在临床试验中评估新疗法疗效的能力。因此，一种能够在患者最少配合的情况下快速、定量、可靠和无创地评估神经肌肉疾病状态的技术不仅可以作为诊断工具，而且可以作为诊断后调整患者护理和简化临床药物试验的一种手段。在这方面显示出巨大前景的一项技术是电阻抗肌动描记术 (EIM)。在过去的十年中，EIM 技术在人类受试者中对各种神经肌肉疾病进行了广泛的研究，这些研究提供了非常有希望的结果，包括证明这些技术不仅可以区分不同的疾病，而且可以帮助准确评估疾病随时间的进展或缓解。然而，几乎所有这些研究都是使用市售阻抗设备进行的，这些设备并未专门针对肌肉健康评估进行优化。因此，第一阶段 SBIR 申请的目标是资助此类设备的初始开发和测试，包括采用新颖的机械传感器技术和电子设备，以在更宽的频率范围内实现比现成系统更高的精度。因此，该项目的具体目标是：1）开发一套坚固的、可重新配置的机械传感器，可以与各种商业阻抗测量设备连接； 2) 开发一种具有新颖电路拓扑的电子阻抗测量系统，专门针对快速、准确和宽带 EIM 测量进行了优化； 3) 在各种测试介质中评估所开发的系统。随着这三个目标的成功实现，我们将能够在临床试验中测试该设备，作为计划的 II 期 SBIR 拨款的一部分。 公共卫生相关性：神经肌肉疾病影响着美国和国外数百万人的生活。用于评估肌肉和神经功能障碍的诊断工具在很大程度上仍然是定性的、不准确的和痛苦的，并且特别难以用于儿童。电阻抗肌动描记 (EIM) 技术在克服这些限制方面显示出巨大的前景。因此，该项目的总体目标是开发一种手持式、无创电阻抗设备，可以对肌肉健康状况进行准确、快速的评估。