基于脑机接口的反应性神经刺激术治疗药物难治性癫痫的研究进展

Advances in Responsive Neurostimulation Based on Brain-Computer Interface for the Treatment of Drug-Resistant Epilepsy.

摘要:

反应性神经刺激术（Responsive neurostimulation, RNS）是一种基于脑机接口的闭环神经刺激术，通过植入颅内的电极实时接收和识别与癫痫发作相关的异常脑电，通过特定算法预测癫痫脑电发作并触发相应的电刺激以减少或控制癫痫发作。自2013年美国食品药品监督管理局(Food and Drug Administration, FDA)批准RNS治疗难治性癫痫以来，有较多的临床报道证实RNS的有效性与安全性，目前国内也开展了RNS的临床试验工作。近年来的研究表明，RNS在减少癫痫发作频率和改善患者生活质量方面表现出较好的长期疗效，但仍需进一步优化设备及算法，以提高治疗精准度和安全性。本文围绕RNS的闭环刺激机制、疗效、安全性及未来发展方向等方面进行综述，从而使更多临床工作者了解该项技术和其研究进展。

Abstract:

Responsive neurostimulation (RNS) is a closed-loop neuromodulation technology based on a brain-computer interface (BCI). By implanting intracranial electrodes, the system continuously monitors and detects abnormal electroencephalographic (EEG) patterns associated with epileptic seizures. Utilizing advanced algorithms, RNS predicts impending seizures and delivers targeted electrical stimulation in real-time to mitigate or suppress seizure activity. Since its 2013 approval by the U.S. Food and Drug Administration (FDA) for drug-resistant epilepsy treatment, numerous clinical studies have demonstrated its efficacy and safety. More recently, clinical trials in China have subsequently validated its therapeutic potential. Emerging evidence suggests that RNS provides sustained long-term benefits in reducing seizure frequency and improving patients' quality of life. However, further optimization of both device components and stimulation algorithms remains necessary to enhance therapeutic precision and safety. This review systematically examines the closed-loop stimulation mechanisms, therapeutic efficacy evaluations, safety assessments, and future development trajectories of RNS, aiming to equip clinicians with updated knowledge regarding this evolving technology and its clinical progress.