神经系统疾病脑机接口临床研究实施与管理的中国专家共识  

Chinese expert consensus on implementation and management of brain-computer interface clinical research in neurological diseases

作　　者：中华医学会神经外科学分会 中国卒中学会脑血管外科分会 王硕[2] 赵继宗 何江弘 涂文军 韩帅 柴晓珂 刘清源 Society of Neurosurgery of Chinese Medical Association;Society of Cerebrovascular Surgery of Chinese Stroke Association;Wang Shuo;Zhao Jizong(不详;Department of Neurosurgery,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;China National Clinical Research Center for Neurological Diseases,Beijing 100070,China)

机构地区：[1]不详 [2]首都医科大学附属北京天坛医院神经外科,北京100070 [3]国家神经系统疾病临床医学研究中心,北京100070 [4]吉林大学第一医院神经外科

出　　处：《中华医学杂志》2024年第23期2105-2112,共8页National Medical Journal of China

基　　金：国家重点研发计划(2021YFC2501100)

摘　　要：脑机接口(BCI)技术的发展及其初步研究成果展现了巨大临床应用前景。特别是在神经系统疾病领域应用BCI技术是目前研究的热点,而当前BCI技术仍停留在实验探索阶段,亟需系统、规范的临床研究验证。为此,本共识由中华医学会神经外科学分会和中国卒中学会脑血管外科分会牵头,在多学科专家的深入研讨和德尔菲法表决的基础上,针对临床前资质审核、临床研究实施与管理以及长期效应跟踪与评估等环节提出了指导意见与原则,以规范研究伦理准则和临床研究流程,进一步推动BCI技术在神经系统疾病治疗中的广泛应用与深入发展。The development of brain-computer interface(BCI)technology and its preliminary research results show great clinical application prospects.In particular,the application of BCI technologyis a hot research topic in the field of nervous system diseases at present,but the current BCI technology is still in the stage of experimental exploration,needing systematic and standardized clinical research validation.For this purpose,the consensus is led by the Society of Neurosurgery of Chinese Medical Association and Society of Cerebrovascular Surgery of Chinese Stroke Association.Based on the in-depth discussion of multidisciplinary experts and the vote of the Delphi Method,the guidelines and principles are proposed for pre-clinical qualification review,clinical research implementation and management,and long-term effect tracking and evaluation,so as to standardize research ethics and clinical research procedures and further promote the extensive application and in-depth development of BCI technology in the treatment of nervous system diseases.

关 键 词：神经系统疾病 脑机接口 专家共识 

分 类 号：R741[医药卫生—神经病学与精神病学]