脑机接口控制机器人训练对亚急性脑卒中患者康复结局的影响：一项随机对照试验
Effects of Training with a Brain-Computer Interface-Controlled Robot on Rehabilitation Outcome in Patients with Subacute Stroke: A Randomized Controlled Trial.
作者信息
Zhao Chen-Guang, Ju Fen, Sun Wei, Jiang Shan, Xi Xiao, Wang Hong, Sun Xiao-Long, Li Min, Xie Jun, Zhang Kai, Xu Guang-Hua, Zhang Si-Cong, Mou Xiang, Yuan Hua
机构信息
Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
Department of Rehabilitation Medicine, China-Japan Friendship Hospital, Beijing, China.
出版信息
Neurol Ther. 2022 Jun;11(2):679-695. doi: 10.1007/s40120-022-00333-z. Epub 2022 Feb 16.
INTRODUCTION
Stroke is always associated with a difficult functional recovery process. A brain-computer interface (BCI) is a technology which provides a direct connection between the human brain and external devices. The primary aim of this study was to determine whether training with a BCI-controlled robot can improve functions in patients with subacute stroke.
METHODS
Subacute stroke patients aged 32-68 years with a course of 2 weeks to 3 months were randomly assigned to the BCI group or to the sham group for a 4-week course. The primary outcome measures were Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) and Fugl-Meyer Assessment for Lower Extremity (FMA-LE). Secondary outcome measures included Fugl-Meyer Assessment for Balance (FMA-B), Functional Ambulation Category (FAC), Modified Barthel Index (MBI), serum brain-derived neurotrophic factor (BDNF) levels and motor-evoked potential (MEP).
RESULTS
A total of 28 patients completed the study. Both groups showed a significant increase in mean LOCTA (sham: P < 0.001, Cohen's d = - 2.972; BCI: P < 0.001, Cohen's d = - 4.266) and FMA-LE (sham: P < 0.001, Cohen's d = - 3.178; BCI: P < 0.001, Cohen's d = - 3.063) scores. The LOCTA scores in the BCI group were 14.89% higher than in the sham group (P = 0.049, Cohen's d = - 0.580). There were no significant differences between the two groups in terms of FMA-B (P = 0.363, Cohen's d = - 0.252), FAC (P = 0.363), or MBI (P = 0.493, Cohen's d = - 0.188) scores. The serum levels of BDNF were significantly higher within the BCI group (P < 0.001, Cohen's d = - 1.167), and the MEP latency decreased by 3.75% and 4.71% in the sham and BCI groups, respectively.
CONCLUSION
Training with a BCI-controlled robot combined with traditional physiotherapy promotes cognitive function recovery, and enhances motor functions of the lower extremity in patients with subacute stroke. These patients also showed increased secretion of BDNF.
TRIAL REGISTRATION
Chinese clinical trial registry: ChiCTR-INR-17012874.
引言
中风总是伴随着艰难的功能恢复过程。脑机接口（BCI）是一种在人脑与外部设备之间建立直接连接的技术。本研究的主要目的是确定使用脑机接口控制的机器人进行训练是否能改善亚急性中风患者的功能。
方法
将年龄在32 - 68岁、病程为2周 - 3个月的亚急性中风患者随机分为脑机接口组或假手术组，进行为期4周的治疗。主要结局指标为洛温斯坦职业疗法认知评估（LOCTA）和下肢Fugl - Meyer评估（FMA - LE）。次要结局指标包括平衡Fugl - Meyer评估（FMA - B）、功能性步行分类（FAC）、改良Barthel指数（MBI）、血清脑源性神经营养因子（BDNF）水平和运动诱发电位（MEP）。
结果
共有28名患者完成了研究。两组患者的平均LOCTA（假手术组：P < 0.001，Cohen's d = - 2.972；脑机接口组：P < 0.001，Cohen's d = - 4.266）和FMA - LE（假手术组：P < 0.001，Cohen's d = - 3.178；脑机接口组：P < 0.001，Cohen's d = - 3.063）评分均显著提高。脑机接口组的LOCTA评分比假手术组高14.89%（P = 0.049，Cohen's d = - 0.580）。两组在FMA - B（P = 0.363，Cohen's d = - 0.252）、FAC（P = 0.363）或MBI（P = 0.493，Cohen's d = - 0.188）评分方面无显著差异。脑机接口组的血清BDNF水平显著更高（P < 0.001，Cohen's d = - 1.167），假手术组和脑机接口组的MEP潜伏期分别下降了3.75%和4.71%。
结论
使用脑机接口控制的机器人进行训练并结合传统物理治疗可促进亚急性中风患者的认知功能恢复，增强其下肢运动功能。这些患者还表现出BDNF分泌增加。
试验注册
中国临床试验注册中心：ChiCTR - INR - 17012874。
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