PDF(Pubmed)
Abstract：
UNASSIGNED: Transcutaneous auricular vagus nerve stimulation (taVNS) has garnered attention for stroke rehabilitation, with studies demonstrating its benefits when combined with motor rehabilitative training or delivered before motor training. The necessity of concurrently applying taVNS with motor training for post-stroke motor rehabilitation remains unclear. We aimed to investigate the necessity and advantages of applying the taVNS concurrently with motor training by an electromyography (EMG)-triggered closed-loop system for post-stroke rehabilitation.
UNASSIGNED: We propose a double-blinded, randomized clinical trial involving 150 stroke patients assigned to one of three groups: concurrent taVNS, sequential taVNS, or sham control condition. In the concurrent group, taVNS bursts will synchronize with upper extremity motor movements with EMG-triggered closed-loop system during the rehabilitative training, while in the sequential group, a taVNS session will precede the motor rehabilitative training. TaVNS intensity will be set below the pain threshold for both concurrent and sequential conditions and at zero for the control condition. The primary outcome measure is the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). Secondary measures include standard upper limb function assessments, as well as EMG and electrocardiogram (ECG) features.
UNASSIGNED: Ethical approval has been granted by the Medical Ethics Committee, affiliated with Zhujiang Hospital of Southern Medical University for Clinical Studies (2023-QX-012-01). This study has been registered on ClinicalTrials (NCT05943431). Signed informed consent will be obtained from all included participants. The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings.
UNASSIGNED: This study represents a pioneering effort in directly comparing the impact of concurrent taVNS with motor training to that of sequential taVNS with motor training on stroke rehabilitation. Secondly, the incorporation of an EMG-triggered closed-loop taVNS system has enabled the automation and individualization of both taVNS and diverse motor training tasks-a novel approach not explored in previous research. This technological advancement holds promise for delivering more precise and tailored training interventions for stroke patients. However, it is essential to acknowledge a limitation of this study, as it does not delve into examining the neural mechanisms underlying taVNS in the context of post-stroke rehabilitation.
UNASSIGNED: We propose a double-blinded, randomized clinical trial involving 150 stroke patients assigned to one of three groups: concurrent taVNS, sequential taVNS, or sham control condition. In the concurrent group, taVNS bursts will synchronize with upper extremity motor movements with EMG-triggered closed-loop system during the rehabilitative training, while in the sequential group, a taVNS session will precede the motor rehabilitative training. TaVNS intensity will be set below the pain threshold for both concurrent and sequential conditions and at zero for the control condition. The primary outcome measure is the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). Secondary measures include standard upper limb function assessments, as well as EMG and electrocardiogram (ECG) features.
UNASSIGNED: Ethical approval has been granted by the Medical Ethics Committee, affiliated with Zhujiang Hospital of Southern Medical University for Clinical Studies (2023-QX-012-01). This study has been registered on ClinicalTrials (NCT05943431). Signed informed consent will be obtained from all included participants. The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings.
UNASSIGNED: This study represents a pioneering effort in directly comparing the impact of concurrent taVNS with motor training to that of sequential taVNS with motor training on stroke rehabilitation. Secondly, the incorporation of an EMG-triggered closed-loop taVNS system has enabled the automation and individualization of both taVNS and diverse motor training tasks-a novel approach not explored in previous research. This technological advancement holds promise for delivering more precise and tailored training interventions for stroke patients. However, it is essential to acknowledge a limitation of this study, as it does not delve into examining the neural mechanisms underlying taVNS in the context of post-stroke rehabilitation.
摘要：
■经皮耳迷走神经刺激（taVNS）引起了中风康复的关注，研究表明，当与运动康复训练结合或在运动训练前交付时，它的好处。尚不清楚将taVNS与运动训练同时应用于中风后运动康复的必要性。我们旨在研究通过肌电图（EMG）触发的闭环系统与运动训练同时应用taVNS进行中风后康复的必要性和优势。
■我们提出了一种双盲，随机临床试验涉及150名中风患者，分为三组：并发taVNS，顺序taVNS,或假控制条件。在并发组中，在康复训练期间，taVNS爆发将通过EMG触发的闭环系统与上肢运动同步，而在顺序组中，运动康复训练之前将进行taVNS课程。TaVNS强度将被设定为低于同时和顺序条件的疼痛阈值,并且对于对照条件为零。主要结果测量是上肢的Fugl-Meyer评估(FMA-UE)。次要措施包括标准的上肢功能评估，以及EMG和心电图（ECG）特征。
■已获得医学伦理委员会的伦理批准，附属南方医科大学珠江医院临床研究（2023-QX-012-01）。本研究已在临床试验（NCT05943431）上注册。签署的知情同意书将从所有参与者获得。研究结果将发表在同行评审的期刊上，并在相关的利益相关者会议上发表。
■这项研究代表了一项开创性的工作，直接比较了并发taVNS与运动训练与顺序taVNS与运动训练对中风康复的影响。其次,EMG触发的闭环taVNS系统的整合使taVNS和多种运动训练任务的自动化和个性化成为可能-这是先前研究中未探索的新颖方法。这项技术进步有望为中风患者提供更精确和量身定制的培训干预措施。然而,必须承认这项研究的局限性，因为它没有深入研究卒中后康复背景下taVNS的神经机制。
■我们提出了一种双盲，随机临床试验涉及150名中风患者，分为三组：并发taVNS，顺序taVNS,或假控制条件。在并发组中，在康复训练期间，taVNS爆发将通过EMG触发的闭环系统与上肢运动同步，而在顺序组中，运动康复训练之前将进行taVNS课程。TaVNS强度将被设定为低于同时和顺序条件的疼痛阈值,并且对于对照条件为零。主要结果测量是上肢的Fugl-Meyer评估(FMA-UE)。次要措施包括标准的上肢功能评估，以及EMG和心电图（ECG）特征。
■已获得医学伦理委员会的伦理批准，附属南方医科大学珠江医院临床研究（2023-QX-012-01）。本研究已在临床试验（NCT05943431）上注册。签署的知情同意书将从所有参与者获得。研究结果将发表在同行评审的期刊上，并在相关的利益相关者会议上发表。
■这项研究代表了一项开创性的工作，直接比较了并发taVNS与运动训练与顺序taVNS与运动训练对中风康复的影响。其次,EMG触发的闭环taVNS系统的整合使taVNS和多种运动训练任务的自动化和个性化成为可能-这是先前研究中未探索的新颖方法。这项技术进步有望为中风患者提供更精确和量身定制的培训干预措施。然而,必须承认这项研究的局限性，因为它没有深入研究卒中后康复背景下taVNS的神经机制。
