中国神经再生研究(英文版) ›› 2022, Vol. 17 ›› Issue (8): 1809-1813.doi: 10.4103/1673-5374.332155

• 原著:脑损伤修复保护与再生 • 上一篇    下一篇

经皮耳迷走神经电刺激联合常规康复训练治疗急性脑卒中患者的疗效和安全性:60例1年随机对照试验

  

  • 出版日期:2022-08-15 发布日期:2022-01-22
  • 基金资助:
    重庆市卫健委医学科研项目(2018ZDXM022,2019MSXM017,2020MSXM106);重庆总医院项目(2019ZDXM03)

Efficacy and safety of transcutaneous auricular vagus nerve stimulation combined with conventional rehabilitation training in acute stroke patients: a randomized controlled trial conducted for 1 year involving 60 patients

Jia-Ni Li1, Chen-Chen Xie1, Chang-Qing Li1, Gui-Fang Zhang1, Hao Tang1, Chuan-Na Jin1, Jing-Xi Ma2, 3, Lan Wen4, Ke-Ming Zhang5, Ling-Chuan Niu1, *#br#   

  1. 1Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China; 2Department of Neurology, Chongqing General Hospital, University of Chinese Academy of Sciences, Chongqing, China; 3Chongqing Key Laboratory of Neurodegenerative Diseases, Chongqing, China; 4Department of Neurology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China; 5Clinical College, Chongqing Medical and Pharmaceutical College, Chongqing, China
  • Online:2022-08-15 Published:2022-01-22
  • Contact: Ling-Chuan Niu, PhD, Niulingchuan@hospital.cqmu.edu.cn.
  • Supported by:
    This work was supported by the Medical Scientific Research Project of Chongqing Municipal Health Commission of China, Nos. 2018ZDXM022, 2019MSXM017 and 2020MSXM106; and a grant from Chongqing General Hospital of China, No. 2019ZDXM03 (all to LCN and JXM).

摘要:

经皮耳迷走神经电刺激是一种较新的,无创的经皮刺激迷走神经耳旁支的脑卒中治疗方法。近年来,有研究显示经皮耳迷走神经电刺激联合常规康复训练可促进急性脑卒中患者神经功能的恢复。但目前仅有小样本研究观察了经皮耳迷走神经电刺激干预脑卒中后亚急性期和慢性期后神经功能的恢复情况。此次实际双盲随机对照试验于 2018 年 11 月至 2020 年 3 月在重庆医科大学附属第二医院招募60例年龄在18-80岁的急性缺血性或出血性脑卒中患者,随机接受经皮耳迷走神经电刺激或假刺激联合常规康复训练。在为期1年的随访中发现,与接受假刺激的患者相比,经皮耳迷走神经电刺激联合常规康复训练可显著改善患者的运动、感觉功能和情绪状态,且无明显副作用。这一结果表明,经皮耳迷走神经电刺激联合常规康复训练治疗急性缺血性或出血性脑卒中安全有效。

https://orcid.org/0000-0003-0574-241X (Ling-Chuan Niu)

关键词: 经皮耳迷走神经电刺激, 脑卒中, 康复训练, 肢体功能障碍, 情绪障碍, 日常生活活动, 神经再生, 随机对照试验

Abstract: Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a novel noninvasive treat-ment for stroke that directly stimulates the peripheral auricular branch of the vagus nerve. There have been recent reports that ta-VNS combined with conventional rehabilitation training promotes the recovery of neurological function of patients with acute stroke. However, these were small-sample-sized studies on the recovery of neurological function in patients after percutaneous vagus nerve stimulation in the subacute and chronic phases after stroke. This double-blinded randomized controlled trial involved 60 acute ischemic or hemorrhagic stroke patients aged 18–80 years who received treatment in the Second Affiliated Hospital of Chongqing Medical University. The subjects were randomly assigned to receive ta-VNS or sham ta-VNS combined with conventional rehabilitation training. The follow-up results over 1 year revealed that ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses compared with sham ta-VNS combined with conventional rehabilitation training. There were no obvious side effects. These findings suggest that ta-VNS combined with conventional rehabilitation training for the treatment of acute ischemic or hemorrhagic stroke patients is safe and effective.

Key words: activity of daily living, early stage treatment, emotional disorder, limb dysfunction, neural regeneration, randomized controlled clinical trial, rehabilitation, safety of treatment, stroke, transcutaneous auricular-vagus nerve stimulation