双语马斯克才把大脑上传云端？落后了！对手已完成脑机接口植入

　　Synchron completes first U.S. human implant of brain-computer interface rivaling Elon Musk’s Neuralink
　　微创介入治疗脑瘫开发者 同步公司 （Synchron） 完成了美国首个与 马斯克（Elon Musk） 的  神经链接公司 （Neuralink）产品相媲美的脑机接口（BCI）人体植入
　　[Image from Synchron]
　　Synchron今天宣布，它在美国完成了第一个人脑-计算机接口（BCI）植入。
　　Synchron announced today that it completed the first-in-human brain-computer interface (BCI) implant in the U.S.
　　该手术在纽约西奈山西区进行，是美国首次采用血管内脑机接口（BCI）方法进行此类植入，而不需要进行侵入性开颅手术。
　　The procedure, performed at Mount Sinai West in New York, represents the first such implant to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery.
　　西奈山伊坎医学院神经外科、神经病学和放射学助理教授Shahram Majidi博士领导了这项手术，该手术采用血管造影套件微创技术进行。今年早些时候，Synchron的神经科学负责人解释了这种导管输送方式如何能够更好地植入大脑。
　　Dr. Shahram Majidi, assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai, led the procedure, which was performed in the angiography suite with a minimally invasive, endovascular approach. Earlier this year, Synchron’s neuroscience chief explained how this type of catheter delivery could enable better brain implants.
　　图 Synchro 公司的脑机接口血管内植入物 Stentrode（来源：Synchron）
　　这是Synchron的＂指令试验＂（Command trial）中的第一个植入患者，在食品和药物管理局研究设备豁免下操作，以评估永久植入的脑机接口BCI。＂指令（Command）＂将评估该公司的脑机接口（BCI）技术的安全性和有效性，包括应用在严重瘫痪患者中使其能够利用免提功能来控制数字设备。据新闻稿称，研究成果包括使用大脑数据来控制数字设备，并提高功能的独立性。
　　It was the first patient implant in Synchron’s Command trial, operating under FDA investigational device exemption to assess a permanently implanted BCI. Command will assess the safety and efficacy of the company’s motor BCI technology, including the Stentrode, in patients with severe paralysis, aiming to enable the patient to control digital devices hands-free. Study outcomes include the use of brain data to control digital devices and achieve improvements in functional independence, according to a news release.
　　Majidi博士在新闻稿中说：＂这对该领域来说是一个令人难以置信的里程碑，因为它的影响和潜力是巨大的。植入手术进行得非常顺利，病人在手术后48小时就可以回家了。＂
　　＂This is an incredibly exciting milestone for the field, because of its implications and huge potential,＂ Majidi said in the release. ＂The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.＂
　　值得注意的是，第一个人体植入的成功实施使Synchron公司的研究进度领先于马斯克的Neuralink公司，后者正致力于开发一种通过机器人辅助程序植入大脑的植入物。
　　Notably, the first-in-human implant pulls Synchron ahead of Elon Musk’s Neuralink, which is working to develop an implant placed in the brain through a robot-assisted procedure.
　　（马斯克的）Neuralink公司的研究对象需要通过头骨植入。虽然马斯克及其公司官员表示计划在2020年向食品和药物管理局申请进行人体试验，但目前尚未获得此批准。今年早些时候，Neuralink和加州大学戴维斯分校被美国医师医药责任协会（PCRM）指控＂严重违反动物福利法＂，并引用了通过公共记录诉讼获得的文件。这些指控声称，Neuralink进行的研究对试验猴子造成了极大的痛苦。
　　Neuralink requires implantation through the skull and, while Musk and company officials said they planned to file for FDA approval for human trials in 2020, it has yet to receive such approval. Earlier this year, Neuralink and the University of California, Davis, were accused of ＂egregious violations of the Animal Welfare Act＂ by the Physicians Committee for Responsible Medicine (PCRM), citing documents obtained through a public records lawsuit. The allegations claimed that Neuralink caused extreme suffering in monkeys.
　　Synchron的植入物（Stentrode）通过颈静脉植入大脑皮层，这是一种微创血管内手术。一旦植入，它就能使用专有的数字语言检测并无线传输运动意图，使严重瘫痪的患者能够通过免提点击控制个人设备。
　　Synchron’s Stentrode is implanted within the major cortex through the jugular vein in a minimally invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control personal devices with hands-free point-and-click.
　　该公司打算继续进行指令（Command）试验，而最近报道的长期安全性测试结果表明，在澳大利亚的一项试验中，该设备在4名患者中安全使用了12个月。
　　The company intends to continue enrollment in the Command trial, while recently reported long-term safety results demonstrated the safe use of the device in four patients out to 12 months in an Australia-based trial.
　　Synchron的首席执行官兼创始人汤姆·奥克斯利（Tom Oxley）博士说：＂美国首次在人体完成血管内脑机接口（BCI）的植入是临床上的一个重大的里程碑，它为瘫痪患者的生活开辟了新的可能性。我们的技术是为数百万失去用手控制数字设备能力的人设计的。我们很高兴能将一种可扩展的脑机接口BCI解决方案推向市场，这一解决方案有可能改变许多人的生活。＂
　　＂The first-in-human implant of an endovascular BCI in the U.S. is a major clinical milestone that opens up new possibilities for patients with paralysis,＂ Synchron CEO and founder Dr. Tom Oxley said. ＂Our technology is for the millions of people who have lost the ability to use their hands to control digital devices. We’re excited to advance a scalable BCI solution to market, one that has the potential to transform so many lives.＂
　　资料来源 SEAN WHOOLEY
　　翻译 JC
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