CEA, LETI, Clinatec, University of Grenoble, Grenoble, France; CHU Grenoble Alpes, Grenoble, France.
CEA, LETI, Clinatec, University of Grenoble, Grenoble, France.
Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.
Approximately 20% of traumatic cervical spinal cord injuries result in tetraplegia. Neuroprosthetics are being developed to manage this condition and thus improve the lives of patients. We aimed to test the feasibility of a semi-invasive technique that uses brain signals to drive an exoskeleton.
We recruited two participants at Clinatec research centre, associated with Grenoble University Hospital, Grenoble, France, into our ongoing clinical trial. Inclusion criteria were age 18-45 years, stability of neurological deficits, a need for additional mobility expressed by the patient, ambulatory or hospitalised monitoring, registration in the French social security system, and signed informed consent. The exclusion criteria were previous brain surgery, anticoagulant treatments, neuropsychological sequelae, depression, substance dependence or misuse, and contraindications to magnetoencephalography (MEG), EEG, or MRI. One participant was excluded because of a technical problem with the implants. The remaining participant was a 28-year-old man, who had tetraplegia following a C4-C5 spinal cord injury. Two bilateral wireless epidural recorders, each with 64 electrodes, were implanted over the upper limb sensorimotor areas of the brain. Epidural electrocorticographic (ECoG) signals were processed online by an adaptive decoding algorithm to send commands to effectors (virtual avatar or exoskeleton). Throughout the 24 months of the study, the patient did various mental tasks to progressively increase the number of degrees of freedom.
Between June 12, 2017, and July 21, 2019, the patient cortically controlled a programme that simulated walking and made bimanual, multi-joint, upper-limb movements with eight degrees of freedom during various reach-and-touch tasks and wrist rotations, using a virtual avatar at home (64·0% [SD 5·1] success) or an exoskeleton in the laboratory (70·9% [11·6] success). Compared with microelectrodes, epidural ECoG is semi-invasive and has similar efficiency. The decoding models were reusable for up to approximately 7 weeks without recalibration.
These results showed long-term (24-month) activation of a four-limb neuroprosthetic exoskeleton by a complete brain-machine interface system using continuous, online epidural ECoG to decode brain activity in a tetraplegic patient. Up to eight degrees of freedom could be simultaneously controlled using a unique model, which was reusable without recalibration for up to about 7 weeks.
French Atomic Energy Commission, French Ministry of Health, Edmond J Safra Philanthropic Foundation, Fondation Motrice, Fondation Nanosciences, Institut Carnot, Fonds de Dotation Clinatec.
约 20%的创伤性颈脊髓损伤导致四肢瘫痪。神经假体正在被开发用于治疗这种疾病,从而改善患者的生活。我们的目的是测试一种使用大脑信号来驱动外骨骼的半侵入性技术的可行性。
我们在法国格勒诺布尔大学医院下属的 Clinatec 研究中心招募了两名参与者参加我们正在进行的临床试验。纳入标准为年龄 18-45 岁,神经功能缺损稳定,患者有额外的移动需求,可进行门诊或住院监测,在法国社会保障系统中登记,并签署知情同意书。排除标准为既往脑手术、抗凝治疗、神经心理学后遗症、抑郁、物质依赖或滥用,以及磁共振成像(MEG)、脑电图(EEG)或 MRI 的禁忌症。一名参与者因植入物的技术问题被排除在外。其余的参与者是一名 28 岁的男子,因 C4-C5 脊髓损伤导致四肢瘫痪。两个双侧无线硬膜外记录器,每个记录器有 64 个电极,被植入大脑上肢感觉运动区。硬膜外脑电(ECoG)信号在线通过自适应解码算法进行处理,以向效应器(虚拟化身或外骨骼)发送命令。在研究的 24 个月中,患者进行了各种心理任务,以逐步增加自由度的数量。
2017 年 6 月 12 日至 2019 年 7 月 21 日,患者通过皮层控制程序,使用在家中使用虚拟化身(64.0%[5.1]成功率)或在实验室使用外骨骼(70.9%[11.6]成功率)进行各种触及任务和手腕旋转,实现了模拟行走和双上肢、多关节、8 自由度的上肢运动。与微电极相比,硬膜外 ECoG 具有半侵入性,效率相似。解码模型可在无需重新校准的情况下重复使用长达约 7 周。
这些结果表明,使用连续在线硬膜外 ECoG 解码四肢瘫痪患者大脑活动的完整脑机接口系统,可以长期(24 个月)激活四肢神经假体外骨骼。使用独特的模型,可以同时控制多达 8 个自由度,无需重新校准即可重复使用约 7 周。
法国原子能委员会、法国卫生部、Edmond J Safra 慈善基金会、Motrice 基金会、Nanosciences 基金会、Carnot 研究所、Clinatec 捐赠基金会。