据“宣武医院神经外科”公众号消息,2022年3月9日,首都医科大学宣武医院院长赵国光教授,神经外科单永治教授带领的神经外科立体定向与功能性脑疾病组团队成功为一名难治性癫痫患者(双侧颞叶癫痫)施行了闭环反应性神经刺激系统Epilcure™注册临床试验植入手术。

手术过程顺利,术中刺激器各项指标均工作正常,术后重建显示电极位置精准,脑电信号清晰。

According to the public account of “Xuanwu Hospital Neurosurgery”, on March 9, 2022, the neurosurgery stereotaxic and functional brain disease team led by Professor Zhao Guoguang, President of Xuanwu Hospital of Capital Medical University, and Professor Shan Yongzhi of Neurosurgery successfully formed a team. A patient with intractable epilepsy (bilateral temporal lobe epilepsy) underwent implantation of the closed-loop reactive neurostimulation system Epilcure™ registration clinical trial.

The operation went smoothly, and all the indicators of the intraoperative stimulator worked normally. The postoperative reconstruction showed that the electrode position was accurate and the EEG signal was clear.

The successful completion of this implantation operation marks the first patient enrollment in the Epilcure™ National Medical Products Administration (NMPA)-registered clinical trial led by Xuanwu Hospital.

According to reports, the patient is male, and was diagnosed with bilateral temporal lobe epilepsy after admission. This type of epilepsy is a relative contraindication to craniotomy, and traditional treatment is not effective in the case of uncontrollable drugs.

The closed-loop reactive neurostimulation system is an important application of “brain-computer interface” in the clinical field. This technology uses artificial intelligence chips to be implanted in the skull, intracranial electrodes are implanted into the brain, and the EEG rhythm is monitored day and night without interruption. The occurrence of epilepsy, that is, the activation of exogenous interference rhythms, directly blocking the formation of epilepsy in the epileptogenic foci, and accurately controlling the activity of the loop.

Surgery implants artificial intelligence chip in patient’s skull

This new technology has brought good news to patients with epilepsy in multifocal or functional areas. The foreign product was approved by the US FDA in 2013, but it has been used as a “neck-stuck” technology for long-term technical blockade and restrictions in my country.

The implantation of this system means that the “brain-computer interface” high-tech product with independent intellectual property rights has reached the final step before full-scale clinical use after the arduous efforts and research of the domestic clinical and basic research team.

该例植入手术的顺利完成标志着由宣武医院作为牵头单位的Epilcure™国家药品监督管理局(NMPA)注册临床试验的首例入组首战告捷。

据介绍,患者为男性,入院后诊断为双侧颞叶癫痫,此类癫痫为开颅手术的相对禁忌症,在药物无法控制的情况下,传统治疗效果欠佳。

闭环反应性神经刺激系统为“脑机接口”在临床领域的重要应用,该技术通过将人工智能芯片植入颅骨,颅内电极植入脑内,昼夜无间断监测脑电节律,一旦预测到即将发生的癫痫,即启动外源性干扰节律,直接阻断致痫灶内的癫痫形成,精准的控制环路的活动。

手术在患者颅内植入了人工智能芯片

这一新技术,为多灶或功能区的癫痫患者带来了福音,国外产品于2013年获得美国FDA认证通过,却作为“卡脖子”技术对我国进行长期技术封锁与限制。

该系统的植入,意味着经过国内临床与基础研究团队艰苦卓绝的努力与攻关,具备自主知识产权的“脑机接口”高新技术产品已经走到了全方位临床使用前的最后一步。

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