The Synchron Stentrode BCI implant senses motor signals from inside the brain’s superior sagittal sinus. [Illustration courtesy of Synchron]Brain-computer interface (BCI) developer Synchron today said there were no serious adverse events in its 12-month Command study, which also showed reliable performance of the Stentrode implant..

Synchron Stentrode BCI植入物感知大脑上矢状窦内部的运动信号。[插图由Synchron提供]脑机接口（BCI）开发人员Synchron今天表示，在为期12个月的Command研究中，没有发生严重的不良事件，这也显示了Stentrode植入物的可靠性能。。

Synchron won FDA breakthrough device designation for the endovascular brain implant in 2020. The Command study is the first investigational device exemption (IDE) trial of a permanently implanted BCI, evaluating safety and efficacy in six patients with severe paralysis.

Synchron于2020年获得FDA血管内脑植入物突破性设备称号。Command研究是第一项永久植入BCI的研究性设备豁免（IDE）试验，评估了六名严重瘫痪患者的安全性和有效性。

Synchron said the feasibility study’s results highlight its system’s “safety profile, stable signal performance, and reliable surgical delivery.”

Synchron说，可行性研究的结果突出了其系统的“安全性、稳定的信号性能和可靠的手术输送”

Instead of open-brain surgery like BCI rival Neuralink‘s implantation procedure, Synchron delivers its nitinol Stentrode implant with a catheter via the jugular and through the brain’s transverse sinus to the superior sagittal sinus for placement. The median deployment time in the study was 20 minutes..

Synchron不是像BCI那样的开放性脑部手术，而是通过颈静脉和大脑的横窦将其镍钛合金支架植入物与导管一起输送到上矢状窦进行放置。。。

Synchron’s brain-computer interface (BCI) system uses the Stentrode brain implant to sense brain signals and relay them to a receiver implant in a patient’s chest. The receiver transmits those brain signals to a decoder, and then the signals are translated into digital commands. [Illustration courtesy of Synchron]Neurosurgeon Dr.

Synchron的脑机接口（BCI）系统使用Stentrode大脑植入物来感知大脑信号，并将其传递给患者胸部的接收器植入物。接收器将这些大脑信号传输到解码器，然后将信号转换为数字命令。[插图由Synchron提供]神经外科医生Dr。

Elad Levy presented the results today at the 2024 Congress of Neurological Surgeons (CNS) in Houston, Texas, calling them “a major medical milestone” in a statement shared with MassDevice ahead of his presentation..

Elad Levy今天在德克萨斯州休斯顿举行的2024年神经外科医生大会（CNS）上介绍了这一结果，并在演讲前与MassDevice分享了一份声明，称其为“一个重要的医学里程碑”。。

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

Levy说：“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。”。

Levy is a co-principal investigator on the study as well as chair of neurosurgery at State University of New York at Buffalo and past president of the CNS Foundation. CNS is awarding Levy with the Duke Samson Award, which recognizes the best clinical paper addressing a topic of cerebrovascular surgery..

Levy是这项研究的联合首席研究员，纽约州立大学布法罗分校神经外科主任，CNS基金会前任主席。CNS授予Levy杜克·萨姆森奖，该奖项表彰针对脑血管手术主题的最佳临床论文。。

In addition to the study’s finding of no impact on the brain or vasculature in the six patients, the study also showed 100% accurate deployment for target motor cortex coverage, demonstrating consistent capture of brain signals related to motor intent and transformation of them into digital motor outputs (DMOs)..

除了该研究发现对六名患者的大脑或脉管系统没有影响外，该研究还显示了目标运动皮层覆盖率的100%准确部署，证明了与运动意图相关的大脑信号的一致捕获以及将其转化为数字运动输出（DMO）。。

Synchron co-founder and CEO Dr. Tom Oxley [Photo courtesy of Synchron]Those DMOs are “simple, thought-derived expressions of intent, converted into digital actions on computers” like scrolls, clicks and double-clicks, Synchron co-founder and CEO Dr. Tom Oxley said. “Making the DMOs easy to use, stable over time and generalizable across technology platforms, will unlock layers of independence and autonomy for patients.”.

Synchron联合创始人兼首席执行官汤姆·奥克斯利博士（照片由Synchron提供）Synchron联合创始人兼首席执行官汤姆·奥克斯利博士说，这些DMO是“简单的，思想衍生的意图表达，转化为计算机上的数字动作”，如滚动、点击和双击。“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。”。

Synchron has recently shown amyotrophic lateral sclerosis (ALS) patients using the Stentrode implant to control Apple Vision Pro headsets, communicate with the help of OpenAI technology, and operate smart home devices with Amazon Alexa.

Synchron最近展示了肌萎缩侧索硬化症（ALS）患者使用Stentrode植入物控制Apple Vision Pro耳机，借助OpenAI技术进行通信，并使用亚马逊Alexa操作智能家居设备。

The Command study was supported by the National Institutes of Health’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The study was conducted at Mount Sinai Health System in New York City, University at Buffalo Neurosurgery and University of Pittsburgh Medical Center (UPMC) in collaboration with Carnegie Mellon University College of Engineering..

这项命令研究得到了美国国立卫生研究院大脑研究所（National Institutes of Health's Brain Research）通过推进创新神经技术（Brain）倡议的支持。这项研究是在纽约市西奈山卫生系统、布法罗神经外科大学和匹兹堡大学医学中心（UPMC）与卡内基梅隆大学工程学院合作进行的。。

With the completion of the feasibility study’s initial follow-up, patients will start enrollment at additional sites next year.

随着可行性研究初步随访的完成，患者将于明年开始在其他地点登记。

Synchron now has five years of data from 10 research participants, Oxley said.

奥克斯利说，Synchron现在拥有来自10名研究参与者的五年数据。

What’s next for Synchron

Synchron的下一步是什么

Oxley said Synchron has a “slightly modified version” of the Stentrode implant coming off the manufacturing line early next year in the Minneapolis metro, with verification and testing happening now.

奥克斯利表示，Synchron公司将于明年年初在明尼阿波利斯地铁生产线推出一款“略微改进版”的Stentrode植入物，目前正在进行验证和测试。

“It’s basically high-quality manufacturing at scale,” he said. “We now have a manufacturing line that can achieve very high standards, very low yields, high quality, very robust, meeting all the FDA testing requirements that are preparing for a for a pivotal-trial-level, commercial-level device.”

“这基本上是大规模的高质量制造，”他说。“我们现在有一条生产线，可以达到非常高的标准，非常低的产量，高质量，非常强大，满足FDA的所有测试要求，这些要求正在为关键的试验级，商业级设备做准备。”

Read more from our interview with Oxley at Medical Design & Outsourcing, including the latest discussions with the FDA about a pivotal trial, lessons learned through the Command study and the potential for consumer use of BCI implants.

阅读我们在医疗设计与外包公司接受Oxley采访的更多信息，包括与FDA关于关键试验的最新讨论，通过Command研究获得的经验教训以及消费者使用BCI植入物的潜力。