背景:在美国,有超过700万中风幸存者,由于脚下垂,许多面临步态障碍。这限制了他们的社区流动,阻碍了功能独立,导致一些长期的健康并发症。尽管有最好的物理治疗,步态功能尚未完全恢复,这主要发生在中风后的急性期。目前治疗选择有限。基于神经生物学原理的新疗法具有导致长期功能改善的潜力。脑机接口(BCI)控制的功能性电刺激(FES)系统就是这样一种策略。它基于Hebbian原则,并在早期的可行性研究中显示出希望。目前的研究描述了BCI-FES临床试验,检查该系统的安全性和有效性,与传统物理疗法(PT)相比,改善中风后慢性步态障碍患者的步态速度。该试验还旨在寻找可能影响或伴随这些改善的其他次要因素,并建立基于Hebbian的康复疗法的潜力。
方法:这项II期临床试验是一项双臂临床试验,随机化,控制,对66名慢性(>6个月)步态障碍阶段的卒中参与者进行纵向研究。参与者接受BCI-FES与PT配对或剂量匹配的PT疗程(每周三次,共四周)。主要结果是步态速度(10米步行测试),次要结果包括步态耐力,运动范围,力量,感觉,生活质量,和神经生理生物标志物。这些措施是纵向获得的。
结论:BCI-FES有望改善卒中患者的步态速度。该临床试验将评估BCI-FES治疗与剂量匹配的常规治疗相比的安全性和有效性。该试验的成功将告知III期疗效试验的潜在效用。
背景:该试验于2020年2月19日在clinicaltrials.gov注册为“BCI-FES治疗中风康复”,标识符为NCT04279067。
BACKGROUND: In the United States, there are over seven million stroke survivors, with many facing gait impairments due to foot drop. This restricts their community ambulation and hinders functional independence, leading to several long-term health complications. Despite the best available physical therapy, gait function is incompletely recovered, and this occurs mainly during the acute phase post-stroke. Therapeutic options are limited currently. Novel therapies based on neurobiological principles have the potential to lead to long-term functional improvements. The Brain-Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) system is one such strategy. It is based on Hebbian principles and has shown promise in early feasibility studies. The current study describes the BCI-FES clinical trial, which examines the safety and efficacy of this system, compared to conventional physical therapy (PT), to improve gait velocity for those with chronic gait impairment post-stroke. The trial also aims to find other secondary factors that may impact or accompany these improvements and establish the potential of Hebbian-based rehabilitation therapies.
METHODS: This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait impairment. The participants undergo either BCI-FES paired with PT or dose-matched PT sessions (three times weekly for four weeks). The primary outcome is gait velocity (10-meter walk test), and secondary outcomes include gait endurance, range of motion, strength, sensation, quality of life, and neurophysiological biomarkers. These measures are acquired longitudinally.
CONCLUSIONS: BCI-FES holds promise for gait velocity improvements in stroke patients. This clinical trial will evaluate the safety and efficacy of BCI-FES therapy when compared to dose-matched conventional therapy. The success of this trial will inform the potential utility of a Phase III efficacy trial.
BACKGROUND: The trial was registered as \"BCI-FES Therapy for Stroke Rehabilitation\" on February 19, 2020, at clinicaltrials.gov with the identifier NCT04279067.