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

基本信息

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
项目类别：
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

项目摘要

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患有神经肌肉疾病的儿童进行快速、无痛、非侵入性评估的方法。小儿神经肌肉疾病包括肌营养不良、脊髓性肌萎缩和炎性肌炎，仅在美国就有超过 100,000 名儿童受到影响。目前评估疾病状态的临床措施（例如肌肉力量测试或哈默史密斯评定量表）在许多方面受到限制，包括其再现性有限、对细微疾病变化缺乏敏感性、强烈依赖于良好的受试者合作、明显的下限和上限效应（即，测试对于非常轻微或非常晚期的疾病没有提供信息），并且需要大量的评估人员专业知识和培训。为了更有效地护理受神经肌肉疾病影响的儿童，非常需要一种无创、无痛的工具，能够在最少的受试者配合下快速、准确地评估疾病状态。这种工具可以用于个体患者，提供有关正在进行的治疗的有效性或改变治疗的潜在需要的有价值的数据。同样重要的是，该工具可以用于临床药物试验，有助于更灵敏、更快速地识别潜在的治疗方法，并且比目前可能的受试者更少，从而大大降低研究成本。我们相信，电阻抗肌电图 (EIM) 就是这样一种工具。在 EIM 中，通过两个表面电极施加不可检测的低强度交流电流，并测量产生的表面电压。多项已发表的成人和儿童研究都支持 EIM 具有高度可重复性并且对疾病状态非常敏感。此外，鉴于其完全非侵入性、无痛的性质，它使其成为一种特别有前途的儿童使用工具。 Convergence Medical Devices, Inc. 将应用 EIM 评估肌肉健康作为其主要关注点和核心能力。第一阶段 SBIR 的具体目标是：(1) 开发一种用于儿童神经肌肉评估的手持式 EIM 设备，(2) 在一组健康成年人中测试该设备，以验证其安全性并产生高质量的 EIM (3) 研究一组 15 名健康儿童和 15 名患有一种相对常见的儿科疾病脊髓性肌萎缩症的儿童，以确定系统的耐受性和可重复性，并初步评估其对健康和疾病状态的敏感性。这三个目标的成功实现将产生一个针对儿童使用而优化的初步原型 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进一步完善设备/软件提供坚实的基础，然后再启动纵向研究评估临床疗效，作为计划的 II 期 SBIR 的一部分。公共卫生相关性：仅在美国就有超过 100,000 名儿童患有一种或多种严重的神经肌肉疾病。然而，目前诊断疾病和评估严重程度的方法不敏感且有限。电阻抗肌电描记技术作为一种提供肌肉健康详细数据且不受当前方法限制的技术，已显示出巨大的前景。因此，该项目的总体目标是开发一种手持式、无创电阻抗装置，可以对儿童的肌肉健康状况进行准确、快速的评估。