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Improving ALS Diagnosis using Needle I-EMG

使用针 I-EMG 改善 ALS 诊断

基本信息

批准号：
9905446
负责人：
Elmer C Lupton
金额：
$ 22.5万
依托单位：
HAYSTACK DIAGNOSTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2021-03-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9905446
关键词：
Adult Affect Agar Age Amyotrophic Lateral Sclerosis Animals Anisotropy Area Atrophic Bilateral Boston Businesses Cachexia Cessation of life Characteristics Clinical Clinical Trials Collaborations Communities Custom Data Data Collection Data Quality Deposition Development Devices Diagnosis Diagnostic Disease Early Diagnosis Electrodes Electromyography Electrophysiology (science)Electrostatics Elements Engineering Evaluation Fatty acid glycerol esters Fee-for-Service Plans Future Harvest Histologic Human Industrialization Israel Letters Manufacturer Name Measurement Measures Medical Medical center Methods Modeling Monitor Mus Muscle Muscle Fibers Myography Myopathy Nature Needles Neuromuscular Diseases Outcome Patients Peripheral Nervous System Phase Physicians Positioning Attribute Process Radiculopathy Reproducibility Rest Riluzole Saline Sampling Shapes Signal Transduction Skin Small Business Innovation Research Grant Specificity Speed Standardization Sterilization Structure Surface Symptoms System Techniques Technology Testing Therapeutic Wild Type Mouse Work base biomaterial compatibility design disability electric impedance electrical property experimental study improved insight interest nervous system disorder novel phase 2 study quadriceps muscle sarcopenia simulation subcutaneous tool

项目摘要

PROJECT SUMMARY Needle electromyography (EMG) remains the standard approach for assessing neuromuscular disease. While the technique has proven to be clinically valuable over the last 80 years, it has important limitations. These include its not being sensitive to alterations in muscle composition and structure, its inability to assess the contractile apparatus of muscle, and its subjective nature with an inter-rater reliability of only 60% and a specificity for disease of only 70%. One technology that could be incorporated seamlessly into the EMG needle to overcome its limitations is electrical impedance myography (EIM). By combining EIM and EMG into a single needle device there is the potential for greatly enhancing the accuracy of EMG, the clinical standard, ultimately yielding a “smarter EMG” technology to evaluate neuromuscular disorders. The development of this new “smarter EMG” technology has been termed needle impedance-electromyography (I-EMG) and it is the main focus of Haystack Diagnostics, Inc., a small business concern based in Boston, MA. In Aim 1 of this Phase 1 SBIR application, Haystack Diagnostics, Inc., will perform finite element simulations to design different I-EMG needles topologies. These needles will be then manufactured on a fee-for-service basis by FHC, Inc., (Bowdoin, ME), a company with which we have previously worked with expertise in custom needle manufacture. In Aim 2, we will test the needle designs in phantom media (saline and agar) and in groups of healthy, wild-type mice and amyotrophic lateral sclerosis (ALS) mice. We will evaluate the EIM and EMG data both independently and together to identify the most effective and robust design, both in terms of repeatability and in differentiating healthy from diseased muscle, comparing to standard EMG as a reference. At the conclusion of this work, Haystack Diagnostics, Inc., will be well positioned to pursue a Phase 2 SBIR application seeking to develop and test I-EMG technology in patients with a variety of neuromuscular diseases, including ALS. With expressed interest from the medical community and Natus Medical, Inc., the world’s largest commercial EMG manufacturer, we believe that if successful, Haystack Diagnostics, Inc., technology could ultimately find wide application in clinical neuromuscular disease practice.

项目概要针肌电图 (EMG) 仍然是评估神经肌肉疾病的标准方法。尽管过去 80 年来，该技术已被证明具有临床价值，但它也有很大的局限性。这些包括它对肌肉成分和结构的变化不敏感，它无法评估肌肉收缩装置及其主观性质，评估者间的可靠性仅为 60%，且对疾病的特异性仅为70%。一项可以无缝融入肌电图针的技术克服其局限性的是电阻抗肌动描记术（EIM）。通过将 EIM 和 EMG 合并为一个针装置有可能大大提高肌电图（临床标准）的准确性，最终产生一种“更智能的肌电图”技术来评估神经肌肉疾病。这一新产品的开发 “更智能的肌电图”技术被称为针阻抗肌电图（I-EMG），它是主要的 Haystack Diagnostics, Inc. 是一家位于马萨诸塞州波士顿的小型企业。在本阶段 1 的目标 1 中 Haystack Diagnostics, Inc. 的 SBIR 应用程序将执行有限元模拟来设计不同的 I-EMG 针拓扑。这些针将由 FHC, Inc. 在按服务收费的基础上制造，（缅因州鲍登），我们之前曾与一家拥有定制针专业知识的公司合作过生产。在目标 2 中，我们将在模型介质（盐水和琼脂）和分组中测试针设计。健康的野生型小鼠和肌萎缩侧索硬化症 (ALS) 小鼠。我们将评估 EIM 和 EMG 数据无论是独立还是共同确定最有效和稳健的设计，无论是在可重复性方面并以标准肌电图作为参考来区分健康肌肉和患病肌肉。在这项工作结束后，Haystack Diagnostics, Inc. 将处于有利地位，可以开展第 2 阶段 SBIR 寻求在患有各种神经肌肉疾病的患者中开发和测试 I-EMG 技术的应用程序，包括肌萎缩侧索硬化症（ALS）。由于医学界和内特斯医疗公司 (Natus Medical, Inc.) 表达了兴趣，世界上最大的商业肌电图制造商，我们相信，如果成功，Haystack Diagnostics, Inc. 的技术最终可以在临床神经肌肉疾病实践中得到广泛应用。

项目成果

期刊论文数量（8）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Electrical impedance myography: A critical review and outlook.

DOI：
10.1016/j.clinph.2020.11.014
发表时间：
2021-03
期刊：
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
影响因子：
0
作者：
Sanchez B;Martinsen OG;Freeborn TJ;Furse CM
通讯作者：
Furse CM

In vivo muscle conduction study of the tongue using a multi-electrode tongue depressor.

DOI：
10.1016/j.clinph.2020.11.010
发表时间：
2021-03
期刊：
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
影响因子：
0
作者：
Luo X;Gutierrez Pulido HV;Rutkove SB;Sanchez B
通讯作者：
Sanchez B

Skin Electrical Resistance as a Diagnostic and Therapeutic Biomarker of Breast Cancer Measuring Lymphatic Regions.

DOI：
10.1109/access.2021.3123569
发表时间：
2021
期刊：
IEEE access : practical innovations, open solutions
影响因子：
0
作者：
Andreasen N;Crandall H;Brimhall O;Miller B;Perez-Tamayo J;Martinsen OG;Kauwe SK;Sanchez B
通讯作者：
Sanchez B

In silicomuscle volume conduction study validatesin vivomeasurement of tongue volume conduction properties using a user tongue array depressor.

在硅肌体积传导研究中，验证了使用用户舌阵列抑制器对舌体积传导特性的体内测量。