科技英语：发热呕吐脑损伤，脑机人体试验安全性被质疑

Neuralink, a company founded by Elon Musk, has encountered technical challenges in its first human trial of a brain implant designed to help paralyzed patients control digital devices through thought.  Neuralink’s brain implant aims to provide paralyzed patients with the ability to operate computers and other digital devices using only their thoughts. The device consists of tiny wires thinner than a human hair, which are implanted in the brain to decode brain signals and translate them into digital actions.
埃隆·马斯克创立的公司Neuralink在首次进行的旨在帮助瘫痪患者通过思维控制数字设备的脑植入物人体试验中遇到了技术挑战。Neuralink的脑植入物旨在为瘫痪患者提供仅用思维操作电脑和其他数字设备的能力。该设备由比人类头发还细的小电线组成，这些电线植入大脑中以解码脑信号并将其转化为数字动作。

In January, Neuralink implanted its device in the brain of its first human patient, Noland Arbaugh, who is paralyzed from the shoulders down due to a 2016 diving accident. The device has enabled Arbaugh to perform digital tasks such as playing video games, browsing the internet, and moving a computer cursor using only his thoughts. Shortly after surgery, Arbaugh surpassed the world record for controlling a cursor with thoughts alone. However, shortly after the surgery, several of the implant’s threads retracted from the brain, resulting in fewer electrodes being able to measure brain signals. Neuralink disclosed this issue last week.
今年一月，Neuralink将其设备植入了首位人体患者诺兰·阿尔博（Noland Arbaugh）的脑中。阿尔博因2016年的一次潜水事故导致肩部以下瘫痪。该设备使阿尔博能够通过思维进行数字任务，例如玩电子游戏、浏览互联网和移动电脑光标。手术后不久，阿尔博超越了仅用思维控制光标的世界纪录。然而，手术后不久，植入物的几根电线从大脑中缩回，导致能够测量脑信号的电极减少。Neuralink上周披露了这一问题。

The retraction of wires is a problem Neuralink has been aware of for years based on prior animal testing. Despite this, the company assessed the risk as low and did not redesign the device. The retraction results in the loss of sensitive electrodes that decode brain signals, which are crucial for the device’s function.
Neuralink基于此前的动物测试，已经意识到电线缩回的问题已有多年。然而，公司评估认为风险较低，因此并未重新设计该设备。电线缩回导致解码脑信号的敏感电极丢失，而这些电极对设备的功能至关重要。

To address the issue, Neuralink made adjustments to the algorithm used by the device to enhance its sensitivity and restore its ability to monitor brain signals. Despite these modifications, the long-term efficacy of this approach remains uncertain. Redesigning the implant’s threads to prevent retraction presents additional risks, such as potential damage to brain tissue if the threads become dislodged or if the device needs to be removed.
为了解决这一问题，Neuralink调整了设备使用的算法，以增强其灵敏度并恢复其监测脑信号的能力。尽管进行了这些调整，但这种方法的长期效果仍不确定。重新设计植入物的电线以防止缩回会带来额外的风险，例如如果电线脱落或设备需要移除，可能会对脑组织造成损害。

The U.S. Food and Drug Administration (FDA) was informed of the potential issue with the wires through data shared by Neuralink during the application process for human trials. Less than a month after Neuralink announced it was cleared to test its brain implants in humans, FDA inspectors identified problems with record-keeping and quality controls for animal experiments at Neuralink’s California research facility. These inspections, which took place from June 12-22 last year, found lapses such as missing calibration records for instruments and lack of quality assurance sign-off on study reports. However, a similar inspection at Neuralink’s Texas facility did not find problems. Despite the identified issues, the FDA spokesperson Carly Pflaum stated that Neuralink provided sufficient information to support the approval of its human trial application. The agency told Reuters it would continue to monitor the safety of patients enrolled in Neuralink’s study.
美国食品药品监督管理局（FDA）在Neuralink的人体试验申请过程中通过公司共享的数据了解到电线可能存在的问题。在Neuralink宣布获准在人类进行脑植入物测试不到一个月后，FDA检查人员在去年6月12日至22日对Neuralink加利福尼亚研究设施进行了检查，发现记录保存和动物实验质量控制方面存在问题。这些问题包括仪器的校准记录缺失和研究报告缺乏质量保证签字。然而，对Neuralink德克萨斯设施的类似检查并未发现问题。尽管发现了这些问题，FDA发言人卡莉·弗劳姆（Carly Pflaum）表示，Neuralink提供了足够的信息支持其人体试验申请的批准。该机构告诉路透社，他们将继续监测Neuralink研究中的患者安全。

During earlier animal tests, some pigs implanted with the device developed brain inflammation called granulomas. This raised safety concerns among Neuralink’s researchers. A subset of pigs developed severe cases, including fever and heaving post-surgery. Neuralink conducted a months-long investigation but could not definitively determine the cause of the granulomas, ultimately concluding that the device and its threads were not to blame.
在早期的动物测试中，一些植入设备的猪出现了称为肉芽肿的脑部炎症。这引起了Neuralink研究人员的安全担忧。一部分猪出现了严重的病例，包括术后发热和呕吐。Neuralink进行了为期数月的调查，但未能确定肉芽肿的具体原因，最终结论是设备及其电线并不是原因。

While the device has demonstrated significant capabilities in enabling paralyzed patients to interact with digital devices, technical issues such as wire retraction and the risk of brain tissue damage need to be addressed. Ongoing monitoring by the FDA and further research will be crucial in ensuring the safety and effectiveness of this innovative technology.
尽管该设备在使瘫痪患者与数字设备互动方面表现出了显著的能力，但诸如电线缩回和脑组织损伤风险等技术问题仍需解决。FDA的持续监测和进一步的研究对于确保这一创新技术的安全性和有效性至关重要。