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经颅直流电刺激联合经皮耳迷走神经刺激对脑卒中后认知障碍的影响:一项随机对照试验的研究方案。

Effect of transcranial direct current stimulation combined with transcutaneous auricular vagus nerve stimulation on poststroke cognitive impairment: a study protocol for a randomised controlled trial.

机构信息

Department of Rehabilitation Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.

Department of Rehabilitation Medicine, the First Affiliated Hospital of Yangtze University, Jingzhou, Hubei, China.

出版信息

BMJ Open. 2024 Apr 10;14(4):e082764. doi: 10.1136/bmjopen-2023-082764.


DOI:10.1136/bmjopen-2023-082764
PMID:38604630
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11015246/
Abstract

INTRODUCTION: Poststroke cognitive impairment is a common complication in stroke survivors, seriously affecting their quality of life. Therefore, it is crucial to improve cognitive function of patients who had a stroke. Transcranial direct current stimulation (tDCS) and transcutaneous auricular vagus nerve stimulation (taVNS) are non-invasive, safe treatments with great potential to improve cognitive function in poststroke patients. However, further improvements are needed in the effectiveness of a single non-invasive brain stimulation technique for cognitive rehabilitation. This study protocol aims to investigate the effect and neural mechanism of the combination of tDCS and taVNS on cognitive function in patients who had a stroke. METHODS AND ANALYSIS: In this single-centre, prospective, parallel, randomised controlled trial, a total of 66 patients with poststroke cognitive impairment will be recruited and randomly assigned (1:1:1) to the tDCS group, the taVNS group and the combination of tDCS and taVNS group. Each group will receive 30 min of treatment daily, five times weekly for 3 weeks. Primary clinical outcome is the Montreal Cognitive Assessment. Secondary clinical outcomes include the Mini-Mental State Examination, Stroop Colour Word Test, Trail Marking Test, Symbol Digit Modalities Test and Modified Barthel Index. All clinical outcomes, functional MRI and diffusion tensor imaging will be measured at preintervention and postintervention. ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of the First Affiliated Hospital of Yangtze University (approval no: KY202390). The results will be submitted for publication in peer-reviewed journals or at scientific conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300076632.

摘要

简介:脑卒中后认知障碍是脑卒中幸存者的常见并发症,严重影响其生活质量。因此,改善脑卒中患者的认知功能至关重要。经颅直流电刺激(tDCS)和经皮耳迷走神经刺激(taVNS)是两种非侵入性、安全的治疗方法,具有改善脑卒中后患者认知功能的巨大潜力。然而,单一非侵入性脑刺激技术在认知康复方面的效果还需要进一步提高。本研究方案旨在探讨 tDCS 和 taVNS 联合应用对脑卒中患者认知功能的影响及神经机制。

方法和分析:这是一项单中心、前瞻性、平行、随机对照试验,共纳入 66 例脑卒中后认知障碍患者,并按 1:1:1 的比例随机分配至 tDCS 组、taVNS 组和 tDCS 和 taVNS 联合组。每组患者每天接受 30 分钟治疗,每周 5 次,共 3 周。主要临床结局指标为蒙特利尔认知评估量表。次要临床结局指标包括简易精神状态检查、Stroop 色词测验、连线测验、符号数字模式测验和改良巴氏指数。所有临床结局指标、功能磁共振成像和弥散张量成像均在干预前和干预后进行测量。

伦理和传播:该试验已获得长江大学第一附属医院伦理委员会的批准(批准号:KY202390)。研究结果将提交给同行评议期刊或科学会议发表。

临床试验注册号:ChiCTR2300076632。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df67/11015246/f138028df4e5/bmjopen-2023-082764f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df67/11015246/477344e5bbf8/bmjopen-2023-082764f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df67/11015246/f138028df4e5/bmjopen-2023-082764f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df67/11015246/477344e5bbf8/bmjopen-2023-082764f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df67/11015246/f138028df4e5/bmjopen-2023-082764f02.jpg

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引用本文的文献

[1]
Protocol for a randomized controlled trial: efficacy and mechanisms of dual-target anodal tDCS in post-stroke cognitive impairment.

Front Hum Neurosci. 2025-8-13

[2]
Research hotspots and frontiers of vagus nerve stimulation in stroke: a bibliometric analysis.

Front Neurosci. 2024-12-11

本文引用的文献

[1]
Transcranial Direct Current Stimulation for Global Cognitive Functioning and Ability in Daily Life Activities in Poststroke Cognitive Impairment: A Systematic Review and Meta-analysis.

Am J Phys Med Rehabil. 2023-11-1

[2]
Systematic review and network meta-analysis of effects of noninvasive brain stimulation on post-stroke cognitive impairment.

Front Neurosci. 2022-12-28

[3]
Research advances in the application of vagus nerve electrical stimulation in ischemic stroke.

Front Neurosci. 2022-10-28

[4]
Transcutaneous Auricular Vagus Nerve Stimulation Enhances Cerebrospinal Fluid Circulation and Restores Cognitive Function in the Rodent Model of Vascular Cognitive Impairment.

Cells. 2022-9-27

[5]
Transcutaneous auricular vagus nerve stimulation in poststroke cognitive impairment: protocol for a randomised controlled trial.

BMJ Open. 2022-10-5

[6]
Home-Based Transcranial Direct Current Stimulation to Enhance Cognition in Stroke: Randomized Controlled Trial.

Stroke. 2022-10

[7]
Assessing the Effect of Simultaneous Combining of Transcranial Direct Current Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation on the Improvement of Working Memory Performance in Healthy Individuals.

Front Neurosci. 2022-7-19

[8]
Post-Stroke Cognitive Impairment: Epidemiology, Risk Factors, and Management.

J Alzheimers Dis. 2022

[9]
Effect of Vagus Nerve Stimulation on Attention and Working Memory in Neuropsychiatric Disorders: A Systematic Review.

Neuromodulation. 2022-4

[10]
World Stroke Organization (WSO): Global Stroke Fact Sheet 2022.

Int J Stroke. 2022-1

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