Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy) Is Safe and Effective at Improving Upper Extremity Function Following Spinal Cord Injury (P7-11.001)

作者: Wecht, Jill ; Janssen, Thomas ; Marino, Ralph ; Gelenitis, Kristen ; Field-Fote, Edelle ; Purcell, Mariel ; D’Amico, Jessica ; Zhao, Kristin ; van Nes, Ilse ; Tefertiller, Candace ; Morse, Leslie ; Turner, Amanda ; Suggitt, Jenny ; Rieger, Markus ; Moritz, Chet ; Krassioukov, Andrei ; Pradarelli, Jared ; Kalsi-Ryan, Sukhvinder ; Trumbower, Randy ; Guest, James ; Murray, Lynda

2018-09-15·Journal of Neurotrauma2区 · 医学

Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis

2区 · 医学

Article

作者: Gad, Parag ; Zhong, Hui ; Turner, Amanda ; Gerasimenko, Yury ; Edgerton, V Reggie ; Terrafranca, Nicholas ; Lee, Sujin

Paralysis of the upper extremities following cervical spinal cord injury (SCI) significantly impairs one's ability to live independently. While regaining hand function or grasping ability is considered one of the most desired functions in tetraplegics, limited therapeutic development in this direction has been demonstrated to date in humans with a high severe cervical injury. The underlying hypothesis is that after severe cervical SCI, nonfunctional sensory-motor networks within the cervical spinal cord can be transcutaneously neuromodulated to physiological states that enable and amplify voluntary control of the hand. Improved voluntary hand function occurred within a single session in every subject tested. After eight sessions of non-invasive transcutaneous stimulation, combined with training over 4 weeks, maximum voluntary hand grip forces increased by ∼325% (in the presence of stimulation) and ∼225% (when grip strength was tested without simultaneous stimulation) in chronic cervical SCI subjects (American Spinal Injury Association Impairment Scale [AIS] B, n = 3; AIS C, n = 5) 1-21 years post-injury). Maximum grip strength improved in both the left and right hands and the magnitude of increase was independent of hand dominance. We refer to the neuromodulatory method used as transcutaneous enabling motor control to emphasize that the stimulation parameters used are designed to avoid directly inducing muscular contractions, but to enable task performance according to the subject's voluntary intent. In some subjects, there were improvements in autonomic function, lower extremity motor function, and sensation below the level of the lesion. Although a neuromodulation-training effect was observed in every subject tested, further controlled and blinded studies are needed to determine the responsiveness of a larger and broader population of subjects varying in the type, severity, and years post-injury. It appears rather convincing, however, that a "central pattern generation" phenomenon as generally perceived in the lumbosacral networks in controlling stepping neuromodulator is not a critical element of spinal neuromodulation to regain function among spinal networks.

项与 Onward Medical SA 相关的新闻（医药）

2024-09-10

·Business Wire

Global Brain-Computer Interfaces Markets 2025-2035: Signal Acquisition Methods and Neural Interfaces - Revolutionizing Neuroprosthetics and Rehabilitation - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "The Global Brain-Computer Interfaces Market 2025-2035" report has been added to ResearchAndMarkets.com's offering. Why This Report Matters: As brain-computer interfaces move from science fiction to reality, understanding the market landscape is crucial for stakeholders across multiple industries. This report offers a wealth of strategic insights to help you identify emerging opportunities and anticipate potential disruptions in your industry. It provides a competitive edge by delivering detailed analysis of cutting-edge Brain-Computer Interface (BCI) technologies and their applications. With comprehensive market sizing and growth projections, the report offers valuable investment guidance to help you make informed decisions. Brain-computer interfaces (BCIs), also known as brain-machine interfaces (BMIs), are systems that establish a direct communication pathway between the human brain and an external device or computer. BCIs read, interpret, and translate brain signals into commands that can control devices or communicate with the outside world, enabling a new form of human-machine interaction. BCIs can restore communication and control capabilities for individuals with severe motor disabilities, such as those with amyotrophic lateral sclerosis (ALS), spinal cord injuries, or locked-in syndrome. BCIs can be used in neurorehabilitation to help patients recover motor functions after stroke, traumatic brain injury, or other neurological disorders. They have the potential to enhance human cognitive and sensory abilities, such as improving memory, attention, or perception, and enabling new forms of human-machine collaboration. Brain-computer interfaces (BCIs) are poised to transform how humans interact with technology, offering groundbreaking applications across healthcare, military, gaming, and beyond. This comprehensive market report provides an in-depth analysis of the rapidly evolving global BCI landscape, examining key technologies, market trends, and growth projections from 2025 to 2040. Additionally, it addresses the complex regulatory and ethical landscape surrounding BCI development and deployment, helping you mitigate risks effectively. Finally, the report outlines an innovation roadmap, offering a clear view of the technological trajectory and future possibilities in human-machine interaction. Report contents include: Overview of BCI fundamentals, covering neural signal acquisition, processing algorithms, and output devices. Historical development of BCIs Analysis of various types, including invasive, semi-invasive, and non-invasive interfaces including key market players, dynamics, and segmentation. Current and emerging BCI technologies including advanced neural interfaces, wireless systems, and AI-enhanced BCIs Competing technologies including eye-tracking and gesture recognition. Signal acquisition methods, including EEG, ECoG, and intracortical microelectrode arrays, as well as innovative approaches like fNIRS and MEG. End-Use Markets and Applications including: Medical and Healthcare: Neuroprosthetics, communication aids for locked-in patients, and cognitive enhancement technologies. Military and Defense: Enhanced soldier performance and silent communication systems. Gaming and Entertainment: BCI-controlled video games and immersive VR/AR experiences. Smart Home and IoT Integration: Seamless control of connected devices. Automotive and Transportation: Driver monitoring and BCI-controlled vehicles. Education and Training: Adaptive learning systems and skill acquisition enhancement. Workplace Productivity: Optimizing human-computer interaction in professional settings. Comprehensive market map and profiles of key players driving BCI innovation. Recent developments, patent analyses, and emerging startups. Overview of venture capital investments, government funding, and corporate R&D expenditures in the BCI sector. Regulatory Environment and Ethical Considerations: The report addresses the complex regulatory landscape surrounding BCIs, including FDA and EU regulations, data privacy concerns, and ethical issues related to cognitive liberty and enhancement. Future regulatory challenges and potential solutions are discussed. Market Challenges and Limitations Forward-looking analysis of technological breakthroughs on the horizon, including next-generation neural interfaces, advanced AI integration, and potential applications in brain-to-brain communication and sensory expansion. Key Features: Market Size and Growth Projections: Detailed forecasts from 2025 to 2040, segmented by technology type, application, end-user, and region. Technology Deep Dives: In-depth analysis of BCI signal acquisition methods, processing algorithms, and output technologies. Application Landscape: Comprehensive overview of BCI use cases across multiple industries. Competitive Intelligence: Market mapping, company profiles, and patent analysis. Investment Insights: Overview of funding trends, key investors, and M&A activity. Regulatory Guide: Analysis of current and future regulatory frameworks governing BCI development and deployment. Ethical Considerations: Exploration of the societal implications and ethical challenges posed by BCI technology. Future Scenarios: Expert projections on emerging applications and technological breakthroughs in the BCI field. Detailed profiles of over 55 companies at the forefront of BCI development including Beijing Xinzhida Neurotechnology Blackrock Neurotech FinalSpark Inclusive Brains Kernel MindAffects Motif Neurotech Neuralink Onward Medical Paradromics Precision Neuroscience Synchron Key Topics Covered: 1 EXECUTIVE SUMMARY 1.1 Definition and Basic Concepts 1.2 Historical Development of BCIs 1.3 Types of BCIs 1.4 Key Components of BCI Systems 1.5 Working Principles of BCIs 1.6 Market Overview and Dynamics 1.6.1 Global BCI Market Size and Growth Projections (2025-2040) 1.7 Market Segmentation 1.8 Market Drivers and Opportunities 1.9 Market Challenges and Restraints 1.10 Market Trends and Future Outlook 2 TECHNOLOGY LANDSCAPE 2.1 Current State of BCI Technology 2.2 Emerging BCI Technologies 2.3 Competing technologies 2.4 BCI Signal Acquisition Technologies 2.5 BCI Signal Processing and Decoding Algorithms 2.6 BCI Output Technologies and Applications 3 END USE MARKETS AND APPLICATIONS 3.1 Medical and Healthcare Applications 3.2 Military and Defense Applications 3.3 Gaming and Entertainment 3.4 Smart Home and IoT Integration 3.5 Automotive and Transportation 3.6 Education and Training 3.7 Workplace and Productivity Applications 4 COMPETITIVE LANDSCAPE 4.1 Overview 4.2 Market map 4.3 Key players 4.4 Recent Developments 4.5 Patents 5 INVESTMENT LANDSCAPE AND FUNDING TRENDS 6 REGULATORY ENVIRONMENT AND ETHICAL CONSIDERATIONS 6.1 Current Regulatory Framework for BCIs 6.2 Data Privacy and Security Regulations 6.3 Ethical Issues in BCI Development and Use 6.4 Future Regulatory Challenges and Potential Solutions 7 MARKET CHALLENGES AND LIMITATIONS 7.1 Technical Challenges 7.2 Biological and Physiological Limitations 7.3 User Acceptance and Adoption Barriers 7.4 Cost and Affordability Issues 7.5 Cybersecurity and Data Protection Concerns 7.6 Ethical and Social Challenges 8 FUTURE OUTLOOK 8.1 Technological Advancements and Breakthroughs 8.2 Emerging Applications 9 COMPANY PROFILES (57 company profiles) 10 APPENDICES 10.1 Glossary of BCI Terms and Technologies 10.2 Research scope and methodology For more information about this report visit https://www.researchandmarkets.com/r/xz420 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

2024-09-01

·动脉网

曾让瘫痪患者1天内恢复行走能力，这家脑机接口企业或在年底冲刺商业化

随着医学研究的不断深入，科研人员对瘫痪的理解也在逐渐加深。近年来，随着脑机接口、神经疗法、干细胞疗法等技术的不断突破，越来越多团队开始尝试重新唤醒瘫痪患者的运动功能。对于荷兰医疗技术公司ONWARD Medical来说，这一目标已近在咫尺。在2023年，该公司全球首次成功在人体内植入神经刺激系统ARC-IM和脑机接口设备，以恢复患者脊髓损伤后上肢的动作和功能，包括手臂、手指等运动。在2024年，这家公司刚刚成功募集了成功募集2000万欧元，将继续驱动脑机接口技术与该公司的ARC-IM疗法相结合，以恢复脊髓损伤后意识驱动的下肢活动能力。从硬膜外电刺激到脑机接口，让瘫痪患者实现“个性化”运动 2014年，瑞士联邦理工学院神经科学研究人员Jocelyne Bloch和Gregoire Courtine成立了ONWARD Medical，这家公司最早专注的技术是硬膜外电刺激技术。这项技术被应用于运动康复领域并非新鲜事。早在30年前，已有多项临床前和临床研究证明，硬膜外电刺激技术能够促进修复脊髓损伤患者的运动功能，特别是行走功能。然而，这项技术带来的疗效并非立竿见影。瘫痪患者在进行硬膜外电刺激治疗时，通常需要数名医生或理疗师辅助完成，坚持长达数月的高强度治疗，才可能成功。成功的概率，以及康复情况都存在不确定性。然而在2018年，Jocelyne Bloch和Gregoire Courtine开发了一项靶向神经技术，将这种不确定转化为了一种普遍的治疗方法。和传统硬膜外电刺激技术不同，靶向神经技术更注重精确刺激脊髓中的特定神经元群体，以恢复运动功能。这一技术的核心在于核心在于识别和激活那些对于运动功能恢复至关重要的神经元亚群。通过靶向神经技术，Jocelyne Bloch和Gregoire Courtine成功让3名慢性截瘫患者重新获得了行走的能力，这项研究也以封面论文形式发表于知名学术杂志《Nature》上。随着脑机接口技术的逐渐成熟，ONWARD Medical有了新的方向。不仅要让瘫痪患者重新站起来、动起来，还要使其能够自主控制运动。于是在2022年，团队在靶向神经技术的基础上加入了AI技术，并将其命名为STIMO-BSI系统。 STIMO-BSI系统包括一个结合高分辨率结构和功能成像的计算模型、电极以及能够快速支持装置特异性刺激神经元的软件。患者可通过软件选择自己所需的运动模式，从而操控身体进行活动。 3名完全瘫痪的患者借助这项技术成功恢复了独立运动能力，能够完成站立、行走、骑自行车和游泳等活动。同时，团队还明确了脊髓神经重塑过程中发挥关键作用的神经元类型，可加速后续对瘫痪患者的康复研究。一年后，团队对设备进行了脑机接口化。患者仅需接入脑机接口，便能让大脑和参与行走的脊髓区域连接起来。另外，该设备可在几分钟内完成校准，维持一年以上的可靠和稳定运行。而这项技术后被命名为ARC疗法，也成为了目前ONWARD Medical商业化的重点。两大技术平台均获得FDA认证截至目前，依托ARC疗法ONWARD Medical已经开发了3款产品，即植入式的 ARC-IM、ARC-BCI 和非植入式的ARC-EX。 ARC-IM由一个可植入的脉冲发生器和导线组成，主要帮助患者恢复手臂、手指等上肢动作和功能。此后，瑞士生物医学研究中心Clinatec开发了一款脑机接口设备。这种脑机接口设备能够收集患者大脑中的信号，并通过人工智能算法解析这些信号背后的意图，然后将信息传递给ARC-IM脊髓刺激器，实现思维驱动的运动。以此为基础，团队开发出了ARC-BCI。 ARC-BCI示意图（图源：PLATO）在2023年9月，Onward Medical宣布完成了首例ARC-BCI的植入。数据结果表明，通过ARC-BCI进行脊髓刺激能保证高的安全性，同时对于瘫痪患者上肢运动恢复具有有效性。而此前，这款设备已经通过试验证明，能够能够增强患者对瘫痪腿部运动的控制。本次研究使得ARC-BCI的治疗领域有了新的突破。而ARC-EX则是通过在皮肤上的电极向脊髓损伤区域发送电流，激活神经纤维、促进神经信号的传递，帮助患者恢复运动功能。和脑机接口设备相比，这款设备能够通过非植入式的方式进行治疗，更快捷且安全。另外，其能够与其他物理治疗灵活、无缝结合，更便于患者进行治疗方案的调整。据悉，ARC-EX已经完成临床试验，60名患者接受了为期四个月的治疗，结果显示72%患者的双手或手臂的力量和功能达到了改善标准，90%患者至少在其中一项指标上有所改善，87%患者生活质量得到了提高。目前，这一治疗方案已经登上了著名学术杂志《Neuromodulation: Technology at the Neural Interface》。如今，Onward Medical植入式与非植入式两大技术平台均已获得了FDA授予的突破性设备称号。其中ARC-EX已向FDA提交了ARC-EX系统的De Novo申请，预计将在2024年底获得商业化批准。多项脑机接口研究取得突破性进展除了Onward Medical团队以外，国际上还有许多科研团队正在探索脑机接口技术与神经调控之间的联系。如在2024年，美国加利福尼亚大学戴维斯分校等机构研究人员通过脑机接口技术，让一位45岁的渐冻症患者恢复了语言功能。科研人员将4个微电极阵列植入患者大脑中负责协调言语的区域。当患者想要说话时，电极记录下相关的神经活动，研究人员再把记录结果解码“翻译”为患者想表达的词汇，显示在屏幕上，最后转换成模拟患者声音的语音播放出来。这也是脑机接口技术首次实现“实时解码功能”的突破。而国内关于脑机接口神经调控的研究也进展迅速。此前，清华大学和宣武医院团队共同进行的无线微创脑机接口临床试验，取得了突破性进展。患者通过脑电活动驱动气动手套实现自主喝水等脑控功能，抓握解码准确率超过90%。另外一名瘫痪患者，则通过无线微创脑机接口实现了意念控制光标移动。而在运动能力恢复方面，复旦大学附属华山医院团队曾帮助两名瘫痪患者恢复站立、步行甚至骑自行车等简单的运动功能，未来有望帮助更多患者恢复行动自由和生活自理能力。而在商业化方面，国产企业臻泰智能正在通过“脑机接口+VR技术+康复机器人”的方式，探索一条帮助瘫痪患者恢复运动功能的新道路。据悉，该团队开发的脑机接口设备脑电波识别准确率可达90%以上，能有效助力神经功能障碍患者进行康复治疗。如今，已有团队在脑机接口与神经调控技术取得了突破性进展，预示着未来在神经调控和人机交互方面的广泛应用。随着脑机接口技术的不断成熟，未来这项技术定能为更多疾病带来治愈的可能。如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

细胞疗法

2024-06-18

·BioSpace

ONWARD® Medical to Highlight Brain-Computer Interface at HLTH Europe Conference

CEO Dave Marver and trial participant Gert-Jan Oskam will discuss ONWARD ARC-BCI™ Therapy during main stage presentation EINDHOVEN, the Netherlands, June 18, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces that the Company will be highlighted in a main stage keynote at HLTH Europe, a premier event for digital health leaders. The conference takes place June 17-20 in Amsterdam, the Netherlands. CEO Dave Marver and trial participant Gert-Jan Oskam will address conference attendees in a keynote on the main stage on June 19, 2024. The pair will discuss how investigational ARC-BCI Therapy uses artificial intelligence to enable thought-driven movement after paralysis, the future of therapies to treat SCI, and Gert-Jan's experience as the first human to be implanted with a brain-computer interface to restore walking. More than 3500 leaders are expected to attend this year’s inaugural HLTH Europe, which began in the US, where it is one of the leading health innovation conferences in the country. To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com. *All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use. About ONWARD Medical ONWARD® Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy™, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA). ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company’s external ARC-EX® or implantable ARC-IM® platforms. ARC Therapy can also be delivered by the Company’s ARC-BCI™ platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control. Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI. Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Brussels and Amsterdam (ticker: ONWD). For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube. For Media Inquiries: Aditi Roy, VP Communications media@onwd.com For Investor Inquiries: Amori Fraser, Finance Director investors@onwd.com Disclaimer Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. All ONWARD Medical devices and therapies referenced here, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™ and ARC Therapy™, are investigational and not available for commercial use.

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