RT期刊文章SR电子T1临时安全性“大脑之门”神经接口系统可行性研究的摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP e1177 OP e1192 10.1212 / WNL。半岛投注体育官网100签证官0000000000201707 11 A1丹尼尔·b·鲁宾A1。Bolu例子A1劳里赤脚A1玛格丽特Bowker A1悉尼美国现金A1大卫陈A1约翰·p·多诺霍A1 Emad n Eskandar A1 Gerhard Friehs A1卡罗尔·格兰特A1杰米·m·亨德森A1罗伯特·f·基尔希A1玫瑰Marujo A1 Maryam马苏德A1斯蒂芬·t·Mernoff A1乔纳森·p·米勒A1乔恩·a·Mukand A1理查德·d·佩恩A1 Jeremy Shefner A1 A1约翰·d·克里希纳诉Shenoy Simeral A1詹妮弗·a .甜A1本杰明·l·沃尔特A1齐夫m·威廉姆斯A1利r .业务年2023 UL //www.ebmtp.com/content/100/11/e1177.abstract AB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 - 75岁的成年人在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