Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial.

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

Med Pub Date : 2024-06-14 Epub Date: 2024-04-19 DOI:10.1016/j.medj.2024.02.014

Anxin Wang, Xue Tian, Di Jiang, Chengyuan Yang, Qin Xu, Yifei Zhang, Shaoqing Zhao, Xiaoli Zhang, Jing Jing, Ning Wei, Yuqian Wu, Wei Lv, Banghua Yang, Dawei Zang, Yilong Wang, Yumei Zhang, Yongjun Wang, Xia Meng

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引用次数: 0

Abstract

Background: Upper limb motor dysfunction is a major problem in the rehabilitation of patients with stroke. Brain-computer interface (BCI) is a kind of communication system that converts the "ideas" in the brain into instructions and has been used in stroke rehabilitation. This study aimed to investigate the efficacy and safety of BCI in rehabilitation training on upper limb motor function among patients with ischemic stroke.

Methods: This was an investigator-initiated, multicenter, randomized, open-label, blank-controlled clinical trial with blinded outcome assessment conducted at 17 centers in China. Patients were assigned in a 1:1 ratio to the BCI group or the control group based on traditional rehabilitation training. The primary efficacy outcome is the difference in improvement of the Fugl-Meyer Assessment upper extremity (FMA-UE) score between two groups at month 1 after randomization. The safety outcomes were any adverse events within 3 months.

Findings: A total of 296 patients with ischemic stroke were enrolled and randomly allocated to the BCI group (n = 150) and the control group (n = 146). The primary efficacy outcomes of FMA-UE score change from baseline to 1 month were 13.17 (95% confidence interval [CI], 11.56-14.79) in the BCI group and 9.83 (95% CI, 8.19-11.47) in the control group (mean difference between groups was 3.35; 95% CI, 1.05-5.65; p = 0.0045). Adverse events occurred in 33 patients (22.00%) in the BCI group and in 31 patients (21.23%) in the control group.

Conclusions: BCI rehabilitation training can further improve upper limb motor function based on traditional rehabilitation training in patients with ischemic stroke. This study was registered at ClinicalTrials.gov: NCT04387474.

Funding: This work was supported by the National Key R&D Program of China (2018YFC1312903), the National Key Research and Development Program of China (2022YFC3600600), the Training Fund for Open Projects at Clinical Institutes and Departments of Capital Medical University (CCMU2022ZKYXZ009), the Beijing Natural Science Foundation Haidian original innovation joint fund (L222123), the Fund for Young Talents of Beijing Medical Management Center (QML20230505), and the high-level public health talents (xuekegugan-02-47).

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脑机接口康复治疗与缺血性中风患者的上肢运动功能：随机对照试验

背景：上肢运动功能障碍是中风患者康复过程中的一个主要问题。脑机接口（BCI）是一种将大脑中的 "意念 "转化为指令的通信系统，已被应用于脑卒中康复。本研究旨在探讨BCI在缺血性脑卒中患者上肢运动功能康复训练中的有效性和安全性：这是一项由研究者发起的多中心、随机、开放标签、空白对照临床试验，在中国的17个中心进行盲法结果评估。患者按1:1的比例分配到BCI组或基于传统康复训练的对照组。主要疗效指标是两组患者在随机分配后第1个月的Fugl-Meyer评估上肢（FMA-UE）评分改善程度的差异。安全性结果为3个月内发生的任何不良事件：共有 296 名缺血性中风患者入组，随机分配到 BCI 组（n = 150）和对照组（n = 146）。BCI组的FMA-UE评分从基线到1个月的主要疗效变化为13.17（95%置信区间[CI]，11.56-14.79），对照组为9.83（95% CI，8.19-11.47）（组间平均差异为3.35；95% CI，1.05-5.65；P = 0.0045）。BCI组有33名患者（22.00%）发生了不良事件，对照组有31名患者（21.23%）发生了不良事件：结论：在传统康复训练的基础上，BCI康复训练可进一步改善缺血性脑卒中患者的上肢运动功能。本研究已在 ClinicalTrials.gov 注册：NCT04387474.Funding：本研究得到了国家重点研发计划（2018YFC1312903）、国家重点研发计划（2022YFC3600600）、首都医科大学临床院系开放项目培训基金（CCMU2022ZKYXZ009）的资助、北京市自然科学基金海淀原始创新联合基金（L222123）、北京市医管中心青年人才基金（QML20230505）、高层次公共卫生人才（xuekegugan-02-47）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Med MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

17.70

自引率

0.60%

发文量

102

期刊介绍： Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.