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