用意念玩“马里奥赛车”？国内首例脑机接口前瞻性临床试验完成

当马里奥赛车在屏幕上疾速漂移时，你或许不会想到，操控这辆虚拟赛车的竟是一位失去四肢的特殊玩家——他通过植入颅内的脑机接口系统，将脑电信号转化为精准的操控指令，在数字世界实现了“意念驾驶”。

A quadruple amputee has successfully operated computer games using only thoughts through a brain-machine interface device, marking a significant milestone in BMI technology development in China.

中国首例无线侵入式脑机接口系统前瞻性临床试验术后项目团队合影留念

这场医学与科技相互交融的背后，是中国脑机接口技术的重大突破。今年3月，在复旦大学附属华山医院的手术室内，这位受试者成功植入了由国内脑机接口科技企业阶梯医疗研发的系统，从而完成了国内首例侵入式脑机接口系统注册前瞻性临床试验。

The participant, who lost all four limbs in a high-voltage electrical accident, received a BMI implant at Shanghai's Huashan Hospital affiliated with Fudan University on March 25. The device was developed by StairMed, a Shanghai-based medical technology company.

阶梯医疗开发的超柔性电极，尺寸极小，仅约头发丝的1/100

阶梯医疗的植入体直径26mm、厚度不到6mm，是全球最小尺寸的脑控植入体，仅硬币大小

经过微创手术，两根头发丝百分之一粗细的超柔性电极被埋入受试者大脑，并连接到一块镶嵌在颅骨上、硬币大小的植入体。通过该植入体，大脑信号能无线传输至外部设备，并转化为计算机可理解的操作指令。

The procedure involved inserting two ultra-flexible electrodes - approximately one-hundredth the thickness of human hair - into his brain. These electrodes connect to a 1-yuan-coin-sized implant embedded in his skull that wirelessly transmits brain signals to external devices, converting neural activity into computer commands.

中国首例无线侵入式脑机接口系统前瞻性临床试验受试者术后一个月脑控玩赛车游戏

经过不到一个月的训练，受试者便实现了下象棋、玩赛车游戏等能力，达到了与普通人控制电脑触摸板相近的水平。“现在我可以通过自己的意念控制电脑，有种心随所动的感觉。”患者感慨道。

Following less than one month of training, the participant achieved control comparable to an able-body's touch pad operation, including playing chess and racing games. "I can now control the computer with my thoughts. It feels like my intentions directly translate into actions," said the participant.

这次试验的顺利开展标志着阶梯医疗成为中国第一家进入临床试验阶段的侵入式脑机接口公司，也是继美国埃隆·马斯克创办的Neuralink之后全球第二家完成此举的公司。

This marks China's first invasive BMI first-in-man clinical trial, making StairMed the second company globally, after Elon Musk-backed Neuralink, to reach the clinical trial stage for invasive BMI technology.

复旦大学附属华山医院路俊锋副教授与阶梯医疗创始人、中国科学院脑智卓越中心研究员赵郑拓博士和李雪博士讨论神经电极在受试者大脑的植入位置

阶梯医疗创始人、中国科学院脑智卓越中心研究员赵郑拓博士

“前瞻性临床试验是走向临床应用的重要里程碑，”阶梯医疗创始人赵郑拓表示。“通过这次试验，我们在小样本的情况下获得了完整的产品确定性。后面要做的工作主要是患者数量的增加，使得最终的结果有统计性的意义。”

"The first-in-man clinical trial is an important milestone toward clinical application," said Zhao Zhengtuo, a cofounder of StairMed. "Through this trial, we have achieved complete product certainty with a small sample size. The next step is to increase the number of participants for statistically significant results."

复旦大学附属华山医院路俊锋副教授与阶梯医疗创始人、中国科学院脑智卓越中心研究员赵郑拓博士和李雪博士讨论神经电极在受试者大脑的植入位置

阶梯医疗创始人、中国科学院脑智卓越中心研究员李雪博士

阶梯医疗创始人李雪介绍，其团队研发的脑控植入体直径26mm、厚度不到6mm，仅硬币大小，厚度为Neuralink同类产品1/2左右，而使用的电极截面积仅为Neuralink所使用电极的1/5到1/7。

StairMed's implant, measuring 26 millimeter in diameter and less than 6mm in thickness, is approximately half the thickness of Neuralink's device, while the electrodes have a cross-sectional area just one-fifth to one-seventh of Neuralink's, said Li Xue, another StairMed cofounder.

CT图像显示阶梯医疗无线侵入式脑机接口系统植入体与颅骨平齐

这一微型化设计使手术创伤大幅降低——仅需在颅骨上开3-5毫米的穿刺孔，将传感器植入大脑约5-8毫米深的位置，而不需要贯穿颅骨。镶嵌在颅骨中的设备与颅骨平齐，头皮缝合之后用手几乎摸不到突起。

Installation requires only a 3-5mm skull perforation, with sensors placed 5-8mm deep in the brain, and the implant sits flush with the skull and is virtually undetectable under the scalp.

复旦大学附属华山医院吴劲松/路俊锋教授团队与阶梯医疗创始人、中国科学院脑智卓越中心研究员赵郑拓博士和李雪博士共同为患者做术前规划

阶梯医疗计划完成3-4例前瞻性临床试验，明年年初启动30到40名受试者参与大规模的多中心注册临床试验。2028年左右，该产品有望进入市场。

StairMed plans to conduct three to four prospective clinical trials, followed by larger multicenter registration trials with 30-40 participants in early 2026. Market entry is anticipated around 2028, pending regulatory approvals.

中国首例无线侵入式脑机接口系统前瞻性临床试验手术现场，吴劲松教授与路俊锋副教授做讨论

中国首例无线侵入式脑机接口系统前瞻性临床试验手术现场，吴劲松教授、路俊锋副教授和李雪博士做讨论

据赵郑拓称，未来的应用可能包括机械臂、智能轮椅和具身智能机器人等医疗领域的控制，为残障群体打开新的希望之门。

Future applications may include control of mechanical arms, wheelchairs, and embodied intelligent robots, according to Zhao.

中国首例无线侵入式脑机接口系统前瞻性临床试验手术现场采集到高质量单神经元信号

这一进展正值中国脑机接口产业驶入快车道之际。今年3月，国家医保局印发了《神经系统类医疗服务价格项目立项指南（试行）》，其中为脑机接口新技术前瞻性单独立项。北京、上海等城市也相继出台了专项政策，聚焦脑机接口产业，支持相关技术的开发和产业化。

The advancement comes as China's BMI research and development has been accelerating. In March, the National Healthcare Security Administration established new pricing categories for BMI procedures. Various local governments, including Beijing and Shanghai, have implemented policies supporting BMI technology development and industrialization.

记者：郑正

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