神经损伤与功能重建2026，Vol.21Issue(6)：358-362,5.DOI:10.16780/j.cnki.sjssgncj.20250970
植入式闭环神经刺激器应用及临床评价浅析
Application and Clinical Evaluation of Implantable Closed-Loop Neurostimulators:A Brief Review
摘要
Abstract
Objective:To analyze the regulatory status of clinical evaluation for implantable closed-loop neurostimulators during registration submissions to the U.S.Food and Drug Administration(FDA),aiming to provide insights for the pre-market clinical evaluation of such products in China.Methods:We retrieved data on the clinical applications and mechanisms of implantable closed-loop neurostimulators,reviewed their market approval status in the U.S.,and summarized and analyzed the clinical evaluation pathways and clinical trial designs for medical devices such as closed-loop spinal cord stimulation(CL-SCS)and closed-loop deep brain stimulation(CL-DBS).Results:The U.S.FDA requires closed-loop stimulators to undergo clinical evaluation via the clinical trial pathway.Clinical trial designs should be based on the intended use,closed-loop mechanism,and target population,while appropriately selecting clinical evaluation endpoints,follow-up durations,and sample sizes.Conclusion:By summarizing the design rationales and protocols for pre-market clinical trials of implantable closed-loop neurostimulators under FDA regulation,this study offers valuable insights that can serve as a reference for the regulatory approval of similar products in China.关键词
闭环/神经刺激器/案例研究/临床评价Key words
closed-loop/neurostimulators/case study/clinical evaluation分类
医药卫生引用本文复制引用
杨洁莹,郭佳莹,樊阳..植入式闭环神经刺激器应用及临床评价浅析[J].神经损伤与功能重建,2026,21(6):358-362,5.基金项目
上海市2024年度"科技创新行动计划"软科学研究领域定向委托项目(医疗器械注册审评新工具、新标准、新方法研究,No.24692122800) （医疗器械注册审评新工具、新标准、新方法研究,No.24692122800）
