@article {Rubine1177作者={丹尼尔·b·鲁宾和a . Bolu例子和劳里赤脚与玛格丽特Bowker和悉尼美国现金和大卫陈和约翰·p·多诺霍Emad n . Eskandar Gerhard Friehs和卡罗尔·格兰特和杰米·m·亨德森和罗伯特·f·基尔希和玫瑰Marujo Maryam马苏德和斯蒂芬·t·Mernoff乔纳森·p·米勒和乔恩·a·Mukand和理查德·d·佩恩和杰里米·Shefner和克里希纳和约翰·d·Simeral诉Shenoy詹妮弗·a .甜蜜和本杰明·l·沃尔特和齐夫m·威廉姆斯和利业务r .}, title ={临时安全性可行性研究的“神经接口系统},体积={100}={11},页面= {e1177——e1192} = {2023}, doi = {10.1212 / WNL。出版商0000000000201707}= {Wolters Kluwer健康,公司代表美国神经病学学会},文摘={背景和目标脑-机接口(bci)正在开发恢复流动性,沟通,和功能独立的人瘫痪。半岛投注体育官网虽然在几十年的临床前数据的支持下,长期植入微电极阵列bci在人类身上的安全性是未知的。我们报告安全潜在的结果,非盲、非随机叫“大脑之门”的可行性研究(NCT00912041),最大、持续时间最长的BCI植入的临床试验。方法18岁的成年人{\ textendash} 75年与脊髓损伤的四肢瘫痪,脑干中风,或运动神经元疾病登记到7临床基地在美国。参与者接受了外科手术植入的1或2微电极阵列的运动皮层主导大脑半球。主要安全结果是device-related严重不良事件(节约)要求设备移出或导致死亡或永久性残疾1年期postimplant评估期间增加。二次结果包括其他不良事件的类型和频率和“大脑之门”的可行性系统控制电脑或其他辅助技术。结果从2004年到2021年,14岁的成年人参加“大脑之门”试验设备外科手术植入。设备植入的平均持续时间是872天,产生12203天的安全经验。有68 device-related不良事件,包括6 device-related节约。最常见的device-related副反应是经皮基座周围皮肤过敏。 There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device.Discussion The BrainGate Neural Interface system has a safety record comparable with other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development.Trial Registration Information ClinicalTrials.gov Identifier: NCT00912041.Classification of Evidence This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explantation, resulting in death, or resulting in permanently increased disability during the 1-year postimplant period.AEs=adverse events; BCIs=brain-computer interfaces; CPM=characters per minute; DBS=deep brain stimulation; IDE=Investigational Device Exemption; NORSE=new-onset refractory status epilepticus; RNS=responsive neurostimulation; SAEs=serious adverse events; SCI=spinal cord injury; UADEs=unanticipated adverse device effects}, issn = {0028-3878}, URL = {//www.ebmtp.com/content/100/11/e1177}, eprint = {//www.ebmtp.com/content/100/11/e1177.full.pdf}, journal = {Neurology} }