Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA; School of Medicine, Case Western Reserve University, Cleveland, OH, USA; US Department of Veterans Affairs, Louis Stokes Cleveland Veterans Affairs Medical Center, Functional Electrical Stimulation Center of Excellence, Rehabilitation R&D Service, Cleveland, OH, USA.
Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA; School of Medicine, Case Western Reserve University, Cleveland, OH, USA; US Department of Veterans Affairs, Louis Stokes Cleveland Veterans Affairs Medical Center, Functional Electrical Stimulation Center of Excellence, Rehabilitation R&D Service, Cleveland, OH, USA.
Lancet. 2017 May 6;389(10081):1821-1830. doi: 10.1016/S0140-6736(17)30601-3. Epub 2017 Mar 28.
People with chronic tetraplegia, due to high-cervical spinal cord injury, can regain limb movements through coordinated electrical stimulation of peripheral muscles and nerves, known as functional electrical stimulation (FES). Users typically command FES systems through other preserved, but unrelated and limited in number, volitional movements (eg, facial muscle activity, head movements, shoulder shrugs). We report the findings of an individual with traumatic high-cervical spinal cord injury who coordinated reaching and grasping movements using his own paralysed arm and hand, reanimated through implanted FES, and commanded using his own cortical signals through an intracortical brain-computer interface (iBCI).
We recruited a participant into the BrainGate2 clinical trial, an ongoing study that obtains safety information regarding an intracortical neural interface device, and investigates the feasibility of people with tetraplegia controlling assistive devices using their cortical signals. Surgical procedures were performed at University Hospitals Cleveland Medical Center (Cleveland, OH, USA). Study procedures and data analyses were performed at Case Western Reserve University (Cleveland, OH, USA) and the US Department of Veterans Affairs, Louis Stokes Cleveland Veterans Affairs Medical Center (Cleveland, OH, USA). The study participant was a 53-year-old man with a spinal cord injury (cervical level 4, American Spinal Injury Association Impairment Scale category A). He received two intracortical microelectrode arrays in the hand area of his motor cortex, and 4 months and 9 months later received a total of 36 implanted percutaneous electrodes in his right upper and lower arm to electrically stimulate his hand, elbow, and shoulder muscles. The participant used a motorised mobile arm support for gravitational assistance and to provide humeral abduction and adduction under cortical control. We assessed the participant's ability to cortically command his paralysed arm to perform simple single-joint arm and hand movements and functionally meaningful multi-joint movements. We compared iBCI control of his paralysed arm with that of a virtual three-dimensional arm. This study is registered with ClinicalTrials.gov, number NCT00912041.
The intracortical implant occurred on Dec 1, 2014, and we are continuing to study the participant. The last session included in this report was Nov 7, 2016. The point-to-point target acquisition sessions began on Oct 8, 2015 (311 days after implant). The participant successfully cortically commanded single-joint and coordinated multi-joint arm movements for point-to-point target acquisitions (80-100% accuracy), using first a virtual arm and second his own arm animated by FES. Using his paralysed arm, the participant volitionally performed self-paced reaches to drink a mug of coffee (successfully completing 11 of 12 attempts within a single session 463 days after implant) and feed himself (717 days after implant).
To our knowledge, this is the first report of a combined implanted FES+iBCI neuroprosthesis for restoring both reaching and grasping movements to people with chronic tetraplegia due to spinal cord injury, and represents a major advance, with a clear translational path, for clinically viable neuroprostheses for restoration of reaching and grasping after paralysis.
National Institutes of Health, Department of Veterans Affairs.
由于高位颈髓损伤,患有慢性四肢瘫痪的人可以通过外周肌肉和神经的协调电刺激来恢复肢体运动,这种电刺激被称为功能性电刺激(FES)。用户通常通过其他保留的、但不相关且数量有限的随意运动(例如面部肌肉活动、头部运动、肩部耸动)来命令 FES 系统。我们报告了一名患有创伤性高位颈髓损伤的患者的发现,他通过植入的 FES 重新激活自己瘫痪的手臂和手,使用自己的皮质信号通过颅内脑机接口(iBCI)来协调伸手和抓握动作。
我们招募了一名参加 BrainGate2 临床试验的参与者,该试验正在进行中,旨在获取关于颅内神经接口设备的安全性信息,并研究四肢瘫痪患者使用皮质信号控制辅助设备的可行性。手术在克利夫兰大学医院医疗中心(美国俄亥俄州克利夫兰)进行。研究程序和数据分析在凯斯西储大学(美国俄亥俄州克利夫兰)和美国退伍军人事务部路易斯斯托克斯克利夫兰退伍军人事务医疗中心(美国俄亥俄州克利夫兰)进行。研究参与者是一名 53 岁的脊髓损伤患者(颈 4 节段,美国脊髓损伤协会损伤量表 A 类)。他在手运动皮层区域接受了两个颅内微电极阵列,4 个月和 9 个月后,在他的右上臂和下臂共植入了 36 个经皮电极,以电刺激他的手、肘部和肩部肌肉。参与者使用电动移动手臂支撑物来提供重力辅助,并在皮质控制下提供肱骨外展和内收。我们评估了参与者用皮质命令瘫痪手臂进行简单的单关节手臂和手部运动以及功能有意义的多关节运动的能力。我们比较了他瘫痪手臂的 iBCI 控制与虚拟三维手臂的控制。这项研究在 ClinicalTrials.gov 注册,编号为 NCT00912041。
颅内植入于 2014 年 12 月 1 日进行,我们仍在继续对参与者进行研究。本报告中包含的最后一次会议是 2016 年 11 月 7 日。点到点目标获取会议于 2015 年 10 月 8 日(植入后 311 天)开始。参与者成功地用虚拟手臂和其次是由 FES 激活的自己的手臂进行了单关节和协调的多关节手臂运动的皮质命令,用于点到点目标获取(准确率为 80-100%)。使用他瘫痪的手臂,参与者自主进行了自我控制的伸手去喝一杯咖啡(在植入后 463 天的一次会议中成功完成了 12 次尝试中的 11 次)和喂自己(植入后 717 天)。
据我们所知,这是第一个报告将植入的 FES+iBCI 神经假体联合用于恢复慢性四肢瘫痪患者因脊髓损伤导致的伸手和抓握运动的案例,这是一个重大进展,为临床可行的神经假体在瘫痪后恢复伸手和抓握功能提供了明确的转化途径。
美国国立卫生研究院,美国退伍军人事务部。