NEW YORK--(BUSINESS WIRE)--Synchron, a brain-computer interface company, today announced positive results from the COMMAND study evaluating the safety and efficacy of the Synchron brain computer interface (BCI) device in six participants over a 12-month period.

纽约--（商业新闻短讯）--脑机接口公司Synchron今天宣布了一项命令研究的积极结果，该研究评估了六名参与者在12个月内使用Synchron脑机接口（BCI）设备的安全性和有效性。

The study results were presented today at the 2024 Congress of Neurological Surgeons in Houston, Texas, by Dr. Elad Levy, Co-Principal Investigator of the COMMAND study and SUNY Distinguished Professor and L. Nelson Hopkins Endowed Chair of Neurosurgery at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo and co-director of the Gates Stroke Center and Cerebrovascular Surgery at Kaleida Health’s Buffalo General Medical Center/Gates Vascular Institute..

该研究结果于今日在德克萨斯州休斯顿举行的2024年神经外科医生大会上公布，由指挥研究联合首席研究员、纽约州立大学杰出教授Elad Levy博士和布法罗大学雅各布斯医学与生物医学科学学院神经外科主任L.Nelson Hopkins捐赠，卡莱达健康布法罗综合医学中心/盖茨血管研究所盖茨中风中心和脑血管外科联合主任。。

The COMMAND study was conducted at three clinical sites: Mount Sinai Health System in New York City, UB Neurosurgery/Gates Vascular Institute and UPMC, in collaboration with Carnegie Mellon University College of Engineering. The study was conducted with support from the NIH BRAIN Initiative. COMMAND enrolled six patients with severe chronic bilateral upper-limb paralysis unresponsive to therapy, all of whom received the BCI implant..

指挥部的这项研究是在三个临床地点进行的：纽约市西奈山卫生系统，UB神经外科/盖茨血管研究所和UPMC，与卡内基梅隆大学工程学院合作。这项研究是在NIH大脑倡议的支持下进行的。指挥部招募了6名对治疗无反应的严重慢性双侧上肢瘫痪患者，所有患者均接受了BCI植入。。

All six patients successfully met the primary endpoint of no device-related serious adverse events resulting in death or permanent increased disability during the 1-year post implant evaluation period. The COMMAND study results reported that patients had no serious adverse events (SAEs) related to the brain or vasculature during the 12-month period..

在植入后1年的评估期间，所有6名患者均成功达到了无器械相关严重不良事件的主要终点，导致死亡或永久性残疾增加。司令部研究结果报告说，患者在12个月内没有发生与大脑或脉管系统相关的严重不良事件（SAE）。。

The study also demonstrated that brain signals related to motor intent can be consistently captured and transformed into digital motor outputs, allowing participants to successfully perform a range of digital tasks. In 100% of cases, the Stentrode device was accurately deployed, achieving target motor cortex coverage in the brain for all six patients.

该研究还表明，与运动意图相关的大脑信号可以持续捕获并转化为数字运动输出，从而使参与者能够成功执行一系列数字任务。在100%的情况下，支架装置被准确部署，实现了所有六名患者大脑中目标运动皮层的覆盖。

The median deployment time was 20 minutes..

部署时间中位数为20分钟。。

“The COMMAND study results represent a major medical milestone, confirming the safety of the Stentrode BCI with no neurologic safety events reported during the 12-month study period,” said Levy, M.D., MBA, FAANS, FACS, Co-Principal Investigator, COMMAND trial, and president of UB Neurosurgery (UBNS).

Levy，M.D.，MBA，FAANS，FACS，联合首席研究员，COMMAND试验和UBNS总裁说：“COMMAND研究结果代表了一个重要的医学里程碑，证实了支架BCI的安全性，在12个月的研究期间没有报告神经系统安全事件。”。

“This minimally-invasive approach has the potential to unlock BCI technology at scale for the millions of patients with paralysis and other mobility challenges.”.

“这种微创方法有可能为数百万瘫痪和其他行动不便的患者大规模解锁BCI技术。”。

“The users were able to generate Digital Motor Outputs (DMOs) with the BCI. These are simple, thought-derived expressions of intent, converted into digital actions on computers,” said Tom Oxley, M.D., Ph.D., CEO & Founder, Synchron, and instructor in the Department of Neurosurgery for Mount Sinai Health System.

西奈山卫生系统神经外科系首席执行官兼创始人、博士汤姆·奥克斯利（Tom Oxley）说：“用户能够通过脑机接口生成数字电机输出（DMO）。这些是简单的，由思维衍生的意图表达，并在计算机上转换为数字动作。”。

“Making the DMOs easy to use, stable over time and generalizable across technology platforms, will unlock layers of independence and autonomy for patients.”.

“使DMO易于使用，随着时间的推移稳定并可在技术平台上推广，将为患者开启独立和自主的层次。”。

The COMMAND study is the first FDA-approved investigational device exemption (IDE) trial of a permanently implanted BCI. The results highlight the Synchron BCI’s safety profile, stable signal performance, and reliable surgical delivery. As an endovascular BCI, the fully internalized system offers long-term signal stability, providing a new path for patients to regain functional independence through digital interfaces..

。结果突出了Synchron BCI的安全性，稳定的信号性能和可靠的手术输送。作为血管内BCI，完全内化的系统提供了长期的信号稳定性，为患者通过数字接口恢复功能独立提供了新的途径。。

The Synchron BCI is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, and intended to restore the capability for severely paralyzed people to control personal devices with hands-free point-and-click..

Synchron BCI通过颈静脉通过微创血管内手术植入大脑运动皮层表面的血管中。一旦植入，它被设计用于检测并无线传输大脑中的运动意图，并旨在恢复严重瘫痪人群通过免提点击控制个人设备的能力。。

For more information about the Synchron BCI and our registry, visit https://synchronbci.com.

有关Synchron BCI和我们的注册表的更多信息，请访问https://synchronbci.com.

About Synchron

关于Synchron

Synchron is a neurotechnology company developing an endovascular brain-computer interface (BCI) designed to restore functionality in people with severe paralysis. The clinical-stage company is developing a neuroprosthesis to restore motor signaling to control digital devices and autonomy for individuals with motor impairment.

Synchron是一家神经技术公司，开发血管内脑-计算机接口（BCI），旨在恢复严重瘫痪患者的功能。临床阶段公司正在开发一种神经假体，以恢复运动信号，从而控制数字设备，并为运动障碍患者提供自主性。

Synchron is headquartered in New York City. For more information, visit www.synchron.com. Follow us @synchroninc..

Synchron总部位于纽约市。。。