MyoRegulator: A Non-Invasive Neuromodulation Device for Treatment of Spasticity in Stroke Patients

MyoRegulator：一种用于治疗中风患者痉挛的非侵入性神经调节装置

基本信息

批准号：
10426390
负责人：
Nader Yaghoubi
金额：
$ 143.49万
依托单位：
PATHMAKER NEUROSYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-02-15 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10426390
关键词：
Affect Anodes Blood Vessels Brain Brain Injuries Brain Stem Cause of Death Cell Nucleus Chairperson Cities Clinical Clinical Research Clinical Trials Collaborations Data Analyses Development Devices Disease Doctor of Medicine Doctor of Philosophy Double-Blind Method Engineering Enrollment Feasibility Studies Feedback France Funding Goals H-Reflex Health Human Impairment Institutes Institutional Review Boards Interneurons Intervention Island Leadership Leg Limb structure Measures Medical Medical Device Medicine Modality Movement Muscle Muscle Spasticity Muscle Tonus Myopathy National Institute of Neurological Disorders and Stroke Nerve Neurons Neurosciences New York Nociception Operative Surgical Procedures Pain Paper Pathway interactions Patients Peripheral Peripheral Nerve Stimulation Peripheral Nerves Pharmacology Phase Phase II Clinical Trials Physical therapy Physiological Physiology Preparation Principal Investigator Publishing Rattus Reflex action Reporting Research Research Design Research Personnel Resistance Risk Robotics Safety Site Soleus Muscle Somatosensory Cortex Specialist Spinal Spinal Cord Stroke Synapses System Technology Testing Therapeutic Training Translating United States National Institutes of Health Vertebral column Veterans Work arm authority base bioelectronics career clinical outcome measures clinical practice clinically relevant college design disability experience feasibility trial neuroregulation novel novel strategies professor programs prototype research and development side effect spasticity stroke patient stroke survivor stroke therapy technology development

项目摘要

PROJECT SUMMARY / ABSTRACT Stroke affects over 7.5 million patients in the U.S, with an estimated 795,000 additional cases of stroke occurring each year. Over 30% of stroke survivors have spasticity, a disorder of muscle tone that can cause striking impairments in functional movement. Pharmacological, surgical and physical treatments to manage spasticity have, at best, short-term efficacy and are confounded by side effects. In this NINDS CREATE Device project, we propose translational activities that will advance through multi-site Phase II clinical trials and regulatory submission a recently developed neuromodulation device that non-invasively treats spasticity using a novel approach that combines trans-spinal direct current stimulation (tsDCS) with simultaneous peripheral nerve stimulation. The implications of the current project are far-reaching changes in clinical practice for treating spasticity using an entirely novel approach based on non-invasive neuromodulation. PathMaker Neurosystems Inc. is a clinical-stage neuromodulation company developing a first-in-class treatment for treating stroke patients with spasticity. Our objective for this NINDS CREATE Device project is to carry out key translational activities that will be essential for advancing this technology through multi-site Phase II clinical trials and regulatory approval as a safe and efficacious new treatment for spasticity. The project consists of 5 Specific Aims: In Specific Aim 1, we will implement a GMP-compliant version of the device (MyoRegulator) for use in a Phase II pivotal clinical study in stroke. In Specific Aim 2, we will implement a compliant Quality Management System (QMS). In Specific Aim 3, we will complete preparations for a Phase II clinical study. In Specific Aim 4, we will complete a multi-site double-blind controlled human clinical study. In Specific Aim 5, we will submit De Novo 510(k) for regulatory approval for MyoRegulator. These Specific Aims will lay the essential groundwork allowing our novel, NIH-funded technology to move rapidly through human clinical trials and to regulatory approval. As our company works to translate the groundbreaking academic studies that have resulted in a novel approach to the treatment of spasticity, NINDS CREATE Device support will advance this breakthrough treatment towards the market and enable an entirely new treatment option for stroke patients with spasticity.

项目概要/摘要美国有超过 750 万名中风患者，估计还有 795,000 例中风病例每年都会发生。超过 30% 的中风幸存者患有痉挛，这是一种肌张力紊乱，可导致功能性运动明显受损。药物、手术和物理治疗来控制痉挛最多只能产生短期疗效，并且会受到副作用的影响。在此 NINDS 创建设备项目，我们建议通过多地点二期临床试验推进转化活动，监管机构提交了一种最近开发的神经调节装置，该装置使用非侵入性方法治疗痉挛一种将经脊柱直流电刺激 (tsDCS) 与同时外周血管刺激相结合的新颖方法神经刺激。当前项目的影响是临床实践的深远变化使用基于非侵入性神经调节的全新方法治疗痉挛。探路者 Neurosystems Inc.是一家临床阶段的神经调节公司，致力于开发一流的治疗方法治疗中风痉挛患者。我们的 NINDS CREATE Device 项目的目标是执行关键转化活动对于通过多地点 II 期临床推进该技术至关重要试验和监管部门批准作为一种安全有效的痉挛新疗法。该项目由5 具体目标：在具体目标 1 中，我们将实现符合 GMP 的设备版本 (MyoRegulator) 用于中风的 II 期关键临床研究。在具体目标 2 中，我们将实施合规质量管理体系（QMS）。在具体目标3中，我们将完成II期临床研究的准备工作。在具体目标4，我们将完成多中心双盲对照人体临床研究。在具体目标 5 中，我们将提交 De Novo 510(k) 以获得 MyoRegulator 的监管批准。这些具体目标将奠定重要的基础工作使我们由 NIH 资助的新技术能够在人体临床试验中快速发展并获得监管部门的批准。当我们公司致力于翻译突破性的学术研究时，产生了一种治疗痉挛的新方法，NINDS CREATE 设备支持将推动这一进程突破性治疗方法推向市场，为中风患者提供全新的治疗选择伴有痉挛。