Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)
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DOI：
10.2196/12339
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发表时间：
2018-12-01
影响因子：
1.7
通讯作者：
Liu, Meigen
中科院分区：
文献类型：
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作者：
Mizuno, Katsuhiro;Abe, Takayuki;Liu, Meigen
背景：我们为脑卒中后严重偏瘫患者开发了脑机接口（BMI）系统，用于检测头皮脑电图（EEG）上的事件相关不同步（ERD），并操作运动驱动的手部矫形器结合神经肌肉电刺激。当单侧感觉运动皮层的兴奋性增加时，ERD就会出现。目的：本研究的目的是评估我们的假设，即使用该BMI系统进行运动训练可以改善常规康复治疗无法改善的严重偏瘫。因此，我们计划并实施了一项随机对照临床试验（RCT）来评估使用BMI系统进行强化康复的有效性和安全性。方法：采用单盲、多中心随机对照试验，招募慢性脑卒中后发病90天以上重度偏瘫患者（N=40）。参与者被随机分配到BMI组（n=20）和对照组（n=20）。BMI组患者每天重复10秒运动尝试操作EEG-BMI 40分钟，然后进行40分钟的常规职业治疗。两周内重复干预10次。对照参与者在没有矫形器伺服作用的情况下进行简单的运动想象，并给予10秒40分钟的电刺激，类似于BMI干预。总体而言，在对照组干预后，每天给予40分钟的常规职业治疗，在2周内重复10次。在干预前（基线）、干预后（后）和干预后4周（随访）对麻痹手的运动功能和电生理表型进行表征。Fugl-Meyer上肢评分在基线和随访之间的改善是本研究的主要结果。结果：招聘于2017年3月开始，2018年7月结束。该试验目前处于数据校正阶段。该RCT预计将于2018年10月31日完成。结论：慢性脑卒中后重度偏瘫患者手指功能改善的干预措施尚未得到广泛认可。本研究结果将为监管审批提供临床数据，并为基于BMI的感觉-运动反馈在诱导神经可塑性和运动恢复中的作用提供新的重要理解。
Background: We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases.Objective: The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system.Methods: We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study.Results: Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018.Conclusions: No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery.