Ultrasound-coupled electrical impedance tomography for assessment of neuromuscular disorders

超声耦合电阻抗断层扫描用于评估神经肌肉疾病

• 批准号: 9908399
• 负责人: Ryan Joseph Halter
• 金额: $ 22.46万
• 依托单位: RYTEK MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-09 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9908399
• 关键词: Adipose tissue; Aging; Algorithms; Amyotrophic Lateral Sclerosis; Asses; Biological Markers; Blood flow; Boston; Businesses; Capital; Characteristics; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Communities; Complement; Computer software; Conditioned Reflex; Coupled; Couples; Coupling; Custom; Data; Data Analyses; Devices; Diagnosis; Disease; Electrodes; Electromyography; Equipment; Evaluation; Face; Fatty acid glycerol esters; Frequencies; Functional disorder; Funding; Future; Genetic screening method; Glean; Health; Heterogeneity; Housing; Human; Human Volunteers; Image; Imaging Device; Imaging Phantoms; Individual; Industrialization; Injury; Intramuscular; Literature; Magnetic Resonance Imaging; Maps; Measurable; Measurement; Measures; Medical; Methods; Monitor; Muscle; Muscular Dystrophies; Myasthenia Gravis; Myography; Myopathy; Myositis; Neuromuscular Diseases; Noise; Orthopedics; Outcome; Output; Pain; Pathology; Patient Care; Patients; Phase; Physical Examination; Physicians; Population; Positioning Attribute; Procedures; Property; Recording of previous events; Records; Saline; Severities; Severity of illness; Skin; Small Business Technology Transfer Research; Specificity; Spinal Muscular Atrophy; System; Technology; Testing; Therapeutic Studies; Time; Tissues; Transducers; Translating; Treatment Efficacy; Ultrasonography; Variant; Vertebral column; base; clinical application; cohort; college; commercialization; compliance behavior; data acquisition; design; effective therapy; electric impedance; electrical impedance tomography; electrical property; feasibility trial; healthy volunteer; human study; image reconstruction; imaging modality; imaging properties; improved; individual patient; individualized medicine; neuromuscular function; new technology; novel therapeutics; phase 2 designs; quantitative imaging; sarcopenia; subcutaneous; tool

PROJECT SUMMARY/ABSTRACT Clinical Need: The coming decades promise a revolution in the therapies available for patients with generalized neuromuscular diseases (GNMDs), including muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, myasthenia gravis, and a variety of acquired myopathies. However, in order to help facilitate this, the academic and industrial clinical research communities need improved biomarkers to assess the impact of their new potential therapies. In addition, once these therapies become approved, these tools will be needed to help in tailoring therapy to the needs of individual patients. Limitations: Current approaches for evaluating GNMD are very limited, with modest sensitivity and uncertain reliability. These methods typically include simple force measurements, electromyography (EMG), or imaging with MRI or ultrasound (US). For example, force measurements require patient cooperation making them very subject dependent with low reliability. EMG is invasive, painful, and generally only provides qualitative outcomes. MRI is very expensive and not able to be performed in a routine clinic visit. Finally, US is extremely convenient since it can be used directly in the clinic, however, it is qualitative and very challenging to perform meaningful quantitative image assessment. Our Product – Ultrasound-coupled Electrical Impedance Tomography (US-EIT) is an electrical property imaging device that integrates with a standard ultrasound probe to provide augmented US imaging. Similar to Doppler imaging for blood flow mapping, our device will be able to be ‘flipped on’ to provide a map of the electrical properties of the underlying muscle tissue. Electrical properties of muscle have been shown through many studies to discriminate healthy from diseased tissue. In fact, electrical impedance myography (EIM) has been extensively used for diagnosing and assessing GNMD; however, this approach is a single local measurement and provides no spatial information regarding muscle pathophysiology. We plan to combine for the first time ever in a commercial setting, electrical impedance imaging with standard US for assessing NMD. We hypothesize that this device will be sufficiently sensitive and specific so as to provide a highly reliable output on muscle health. Specific Objectives: We specifically propose to design a sonolucent electrode array and housing that seamlessly integrates to a standard US probe. Secondly, we will evaluate our technology’s repeatability and ability to evaluate muscular dystrophy (i.e. distinguish healthy from diseased muscle) in a small feasibility trial in humans. Future Directions: RyTek Medical is a small company developing bioimpedance-sensing devices for a variety of clinical applications. This device will complement our existing efforts. By the end of this Phase 1 effort, we will have demonstrated that the US-EIT probe is functional in a human population and we will have provided evidence that this approach can distinguish healthy from diseased muscle. This will position us for Phase 2 funding focused on conducting a clinical trial aimed at assessing muscular dystrophy progression and preparing for a 510(k) or IDE application to the FDA.

项目摘要/摘要 临床需求：未来几十年有望在患者可用的疗法中进行革命 普遍的神经肌肉疾病（GNMD），包括肌肉营养不良，肌萎缩性侧索硬化， 脊柱肌肉萎缩，肌无力，重症肌肉和各种肌病。但是，为了帮助 促进这一点，学术和工业临床研究社区需要改进的生物标志物来评估 他们新的潜在疗法的影响。此外，一旦这些疗法获得批准，这些工具将 需要帮助针对个别患者的需求调整治疗。限制：当前的方法 评估GNMD非常有限，具有适度的灵敏度和不确定的可靠性。这些方法通常 包括简单的力测量，肌电图（EMG）或MRI或超声（US）成像。为了 例如，力量测量需要患者合作，使他们非常依赖于较低的主题 可靠性。 EMG具有侵入性，痛苦，通常只提供定性结果。 MRI非常昂贵 并且无法在常规诊所访问中进行。最后，我们非常方便，因为它可以使用 但是，直接在诊所中，执行有意义的定量图像是定性的，非常挑战 评估。我们的产品 - 超声耦合电阻抗层析成像（US-EIT）是 与标准超声探针集成以提供增强的电气特性成像设备 成像。类似于用于血流映射的多普勒成像，我们的设备将能够“翻转”以提供 基础肌肉组织的电特性图。肌肉的电特性已经 通过许多研究表明，将健康与解剖组织区分开。实际上，电阻抗 密术（EIM）已广泛用于诊断和评估GNMD；但是，这种方法是 单个局部测量，没有提供有关肌肉病理生理学的空间信息。我们计划 在商业环境中，首次将电阻抗成像与标准US合并 评估NMD。我们假设该设备将非常敏感和特定，以便提供 高度可靠的肌肉健康产量。特定目标：我们专门提议设计一个声音 电极阵列和外壳无缝集成到标准的美国探针中。其次，我们将评估我们的 技术的可重复性和评估肌营养不良症的能力（即，与众不同的健康 肌肉）在人类的一项小型可行性试验中。未来指示：Rytek Medical是一家小公司 开发用于各种临床应用的生物阻抗感应设备。该设备将完成我们的 现有的努力。到这一阶段1的努力结束时，我们将证明US-EIT探针是 在人口中发挥作用，我们将提供证据表明这种方法可以区分健康 来自解剖的肌肉。这将使我们获得第2阶段资金，重点是进行针对的临床试验 评估肌肉营养不良的进展，并为510（k）或IDE应用于FDA的准备。