PT -期刊文章盟-丹尼尔·b·鲁宾AU - a Bolu例子AU -劳里赤脚AU -玛格丽特Bowker盟-悉尼美国现金AU -大卫陈盟-约翰·p·多诺霍盟Emad n Eskandar盟Gerhard Friehs AU -卡罗尔·格兰特盟杰米·m·亨德森AU -罗伯特·f·基尔希盟-玫瑰Marujo盟Maryam马苏德盟——斯蒂芬·t·Mernoff盟——乔纳森·p·米勒AU -乔恩·a·Mukand盟理查德·d·佩恩AU -杰里米Shefner盟盟——约翰·d·克里希纳诉Shenoy Simeral盟——詹妮弗·a .甜盟——本杰明·l·沃尔特AU -齐夫m·威廉姆斯盟利r . Hochberg TI -临时安全性的可行性研究神经接口系统援助- 10.1212 / WNL“大脑之门”。0000000000201707 DP - 2023年3月14日TA -神经病半岛投注体育官网学PG - e1177 e1192 VI - 100 IP - 11 4099 - //www.ebmtp.com/content/100/11/e1177.short 4100 - //www.ebmtp.com/content/100/11/e1177.full所以Neurology2023 3月14日;100 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。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

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