A device for rapid, painless, bedside muscle evaluation of children

用于快速、无痛、床边儿童肌肉评估的设备

• 批准号: 8124105
• 负责人: Jose Luis Bohorquez
• 金额: $ 19.03万
• 依托单位: MYOLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-10-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8124105
• 关键词: Adult; Affect; Age; Area; Child; Child Care; Child Support; Childhood; Clinical; Clinical Treatment; Clinical Trials; Computer software; Data; Devices; Diagnostic; Disease; Effectiveness; Electrodes; Electronics; Ensure; Evaluation; Fatty acid glycerol esters; Floor; Foundations; Frequencies; Functional disorder; Goals; Hand; Health; Individual; Inflammatory; Injury; Letters; Longitudinal Studies; Measurement; Measures; Medical Device; Methods; Monitor; Muscle; Muscle Fibers; Muscular Dystrophies; Myography; Myositis; Nature; Neurologist; Neuromuscular Diseases; Outcome; Painless; Patient Care; Patients; Pharmaceutical Preparations; Phase; Publishing; Questionnaires; Recruitment Activity; Reproducibility; Reproducibility of Results; Resistance; Role; Safety; Severities; Shapes; Small Business Innovation Research Grant; Spinal Muscular Atrophy; Surface; System; Techniques; Testing; Thick; Tissues; Training; United States; Variant; Work; Wrist; advanced disease; biceps brachii muscle; clinical efficacy; cost; design; disease diagnosis; electric impedance; flexibility; improved; innovation; insight; muscle strength; neuromuscular; novel; prototype; quadriceps muscle; rapid technique; sensor; subcutaneous; tibialis anterior muscle; tool; treatment trial; voltage

DESCRIPTION (provided by applicant): Our goal is to provide neurologists and other clinicians a method for the rapid, painless, non-invasive evaluation of children with neuromuscular disease. Pediatric neuromuscular disorders include muscular dystrophies, spinal muscular atrophy, and inflammatory myositis, and affect well over 100,000 children in the United States alone. Present-day clinical measures to assess disease status such as muscle strength testing or the Hammersmith rating scale are limited in a number of ways, including their having limited reproducibility, a lack of sensitivity to subtle disease change, their being strongly dependent on excellent subject cooperation, marked floor and ceiling effects (i.e., the tests are uninformative in very mild or very advanced disease), and their requiring considerable evaluator expertise and training. In order to care for children affected by neuromuscular disorders more effectively, a non-invasive and painless tool that can rapidly and accurately assess disease status with minimal subject cooperation is greatly needed. Such a tool could be used with individual patients, providing valuable data on the effectiveness of ongoing treatment or the potential need to alter therapy. Equally important, the tool could be used in clinical drug trials, helping to identify potential therapies more sensitively, more quickly and with fewer subjects than currently possible, thus greatly reducing study cost. Electrical impedance myography (EIM), we believe, is such a tool. In EIM, non-detectible, low- intensity, alternating electrical current is applied through two surface electrodes and resulting surface voltages are measured. Multiple published studies, both in adults and children, support that EIM is both highly reproducible and very sensitive to disease status. Moreover, given its entirely non-invasive, painless nature, it makes it an especially promising tool for use in children. Convergence Medical Devices, Inc. has as its primary focus and core competency the application of EIM for the assessment of muscle health. The specific aims of this Phase I SBIR, are to: (1) develop a hand-held EIM device for neuromuscular assessment in children, (2) test the device in a group of healthy adults to verify that it is safe and yields quality EIM data, and (3) study a group of 15 healthy children and 15 children with one relatively common pediatric disease, spinal muscular atrophy, to identify the system's tolerances and repeatability and preliminarily assess its sensitivity to health and disease status. The successful completion of these three aims will yield a preliminary prototype EIM device optimized for use in children. The insights we obtain using this device in both healthy and diseased children will offer a strong foundation for further device/software refinement necessary before launching a longitudinal study assessing clinical efficacy as part of a planned Phase II SBIR. PUBLIC HEALTH RELEVANCE: Over 100,000 children in the United States alone suffer from one or more serious neuromuscular diseases. However, current methods for diagnosing disease and assessing severity are insensitive and limited. The technique of electrical impedance myography has shown great promise as a technique for providing detailed data on muscle health without the limitations of current methods. 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 in children.

描述（由申请人提供）： 我们的目标是为神经科医生和其他临床医生提供一种对神经肌肉疾病儿童进行快速，无痛，无创的评估的方法。小儿神经肌肉疾病包括肌肉营养不良，脊柱肌肉萎缩和炎症性肌炎，仅在美国就影响了100,000多名儿童。当前的临床措施评估疾病状况，例如肌肉力量测试或锤子匠评级量表受到多种方式的限制，包括它们的可重复性有限，对微妙疾病变化的敏感性缺乏敏感性，强烈依赖于出色的主题合作，明显的地板和天花板效应（即，测试都非常温和或非常高级的疾病，以及他们的高级疾病以及他们的专业疾病，以及他们的专业疾病，以及他们的专业疾病），以及他们的良好疾病。为了更有效地照顾受神经肌肉疾病影响的儿童，非常需要一种无创和无痛的工具，可以快速，准确地评估疾病状况，以最少的学科合作评估疾病状况。这种工具可以与个别患者一起使用，提供有关持续治疗有效性或改变治疗需求的有价值数据。同样重要的是，该工具可以用于临床药物试验中，有助于更敏感，更快，更迅速地识别潜在疗法的受试者比目前可能更少，从而大大降低了研究成本。我们认为，电阻抗密闭（EIM）就是这样的工具。在EIM中，通过两个表面电极应用了不可检测的低强度，交替的电流，并测量所得的表面电压。在成人和儿童中，多个发表的研究都支持EIM高度可重现且对疾病状况非常敏感。此外，鉴于其完全没有侵入性，无痛的性质，它使其成为儿童使用的特别有希望的工具。 Contergence Medical Devices，Inc。是其主要重点和核心竞争力，它在评估肌肉健康方面的应用。该阶段I SBIR的具体目的是：（1）开发一种用于儿童神经肌肉评估的手持EIM设备，（2）（2）测试一组健康的成年人中的设备，以验证它是安全的并产生了优质的EIM数据，并且（3）研究一组15个健康的儿童和15个相对常见的儿童，并且可以识别一个相对常见的儿童，以识别培养基，以识别肌肉的肌肉，并识别出肌肉的一部分，以识别肌肉的一部分，并识别出一定的肌肉，并识别出肌肉的一部分，并且识别了肌肉的一部分，并识别出一定的肌肉，并且识别了肌肉的一部分，并且可以识别一个较常见的儿童。它对健康和疾病状况的敏感性。这三个目标的成功完成将产生优化用于儿童的初步原型EIM设备。我们在健康和患病儿童中使用该设备获得的见解将为您提供良好的基础，以在进行纵向研究，以评估临床疗效作为计划的II期SBIR的一部分之前，为进一步的设备/软件改进提供了必要的基础。 公共卫生相关性： 仅在美国，就有100,000多名儿童患有一种或多种严重的神经肌肉疾病。但是，当前诊断疾病和评估严重程度的方法不敏感且有限。电阻抗技术的技术表现出了巨大的希望，作为提供有关肌肉健康的详细数据而没有当前方法的局限性的技术。因此，该项目的总体目标是开发手持，无创的电阻抗装置，该设备可以对儿童的肌肉健康进行准确，快速评估。