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经皮耳迷走神经电刺激联合高频重复经颅磁刺激对卒中后认知障碍的疗效及机制研究
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注册号：

Registration number：

 ChiCTR2500111388 

最近更新日期：

Date of Last Refreshed on：

 2025-10-30 15:40:12 

注册时间：

Date of Registration：

 2025-10-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经皮耳迷走神经电刺激联合高频重复经颅磁刺激对卒中后认知障碍的疗效及机制研究

Public title：

Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Electrical Stimulation Combined with High-Frequency Repetitive Transcranial Magnetic Stimulation in Post-Stroke Cognitive Impairment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经皮耳迷走神经电刺激联合高频重复经颅磁刺激对卒中后认知障碍的疗效及机制研究

Scientific title：

Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Electrical Stimulation Combined with High-Frequency Repetitive Transcranial Magnetic Stimulation in Post-Stroke Cognitive Impairment

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李疏影 

研究负责人：

李雪静 

Applicant：

Li Shuying 

Study leader：

Li Xuejing 

申请注册联系人电话：

Applicant telephone：

 +86 180 1519 3551

研究负责人电话：

Study leader's
telephone：

+86 139 1510 3901

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 lishuying23@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 lixuejing914@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 淮安市第二人民医院

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

江苏省淮安市淮海南路 62 号

研究负责人通讯地址：

江苏省淮安市淮海南路 62 号

Applicant address：

62 Huaihai South Road, Huai'an City, Jiangsu Province, China

Study leader's address：

62 Huaihai South Road, Huai'an City, Jiangsu Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

淮安市第二人民医院

Applicant's institution：

The Second People's Hospital of Huai'an City

研究负责人所在单位：

淮安市第二人民医院

Affiliation of the Leader：

The Second People's Hospital of Huai'an City

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 HEYLL202590

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

淮安市第二人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Huai'an Second People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-15 00:00:00

伦理委员会联系人：

朱延焱

Contact Name of the ethic committee：

Zhu Yanyan

伦理委员会联系地址：

江苏省淮安市淮海南路 62 号

Contact Address of the ethic committee：

62 Huaihai South Road, Huai'an City, Jiangsu Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 6167 3169

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

淮安市第二人民医院

Primary sponsor：

The Rehabilitation Medicine Department of Huai'an Second People's Hospital

研究实施负责（组长）单位地址：

江苏省淮安市淮海南路 62 号

Primary sponsor's address：

62 Huaihai South Road, Huai'an City, Jiangsu Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

淮安

Country：

China

Province：

Jiangsu

City：

Huai'an

单位(医院)：

淮安市第二人民医院

具体地址：

江苏省淮安市淮海南路 62 号

Institution
hospital：

The Second People's Hospital of Huai'an City

Address：

62 Huaihai South Road, Huai'an City, Jiangsu Province, China

经费或物资来源：

淮安市第二人民医院康复医学科

Source(s) of funding：

The Rehabilitation Medicine Department of Huai'an Second People's Hospital

研究疾病：

卒中后认知障碍  

Target disease：

Post-Stroke Cognitive Impairment

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.以随机对照试验设计，系统验证经皮迷走神经刺激（taVNS）单独应用及与高频重复经颅磁刺激（HF-rTMS）在同步、序贯两种联合模式下，对卒中后认知障碍（PSCI）的治疗效果。 2.利用静息态功能性磁共振成像（rs-fMRI）技术，深入探究联合刺激对PSCI患者神经网络连接及神经电生理活动的影响，揭示其改善认知功能的潜在神经机制。 3.分析简易精神状态量表（MMSE）、蒙特利尔认知评估量表（MoCA）等评估结果与神经影像学的内在关联，为PSCI治疗效果的精准评估提供科学依据。  

Objectives of Study：

1. Using a randomized controlled trial design, systematically verify the therapeutic effects of percutaneous vagus nerve stimulation (taVNS) alone and in combination with high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) in both synchronous and sequential modes on post-stroke cognitive impairment (PSCI). 2. Utilizing resting-state functional magnetic resonance imaging (rs-fMRI) technology, deeply explore the impact of combined stimulation on the neural network connections and neuroelectrophysiological activities of PSCI patients, and reveal the potential neural mechanisms underlying its improvement of cognitive function. 3. Analyze the intrinsic correlations between assessment results of scales such as the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) and neuroimaging, providing scientific basis for the precise evaluation of the therapeutic effects of PSCI treatment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. 既往有颅脑外伤史（格拉斯哥昏迷评分<=12分）或接受过颅脑手术者。 2. 合并帕金森病、癫痫（近1年内有发作史）、阿尔茨海默病等可能独立导致认知障碍的神经退行性疾病或发作性疾病者。 3. 体内植入电子医疗器械（如心脏起搏器、深部脑刺激器）、脑内金属异物（非钛合金材质）或行脑室-腹腔分流术者。 4. 佩戴人工耳蜗、存在二度及以上房室传导阻滞或哮喘急性发作期者。 5. 健侧或患侧运动区经标准参数（刺激强度80%-120%静息运动阈值）重复经颅磁刺激无法诱发出运动诱发电位（MEP）者。 6. 脑卒中发生前已存在认知功能下降或确诊精神疾病（如精神分裂症、重度抑郁症）者。 7. 合并严重器官功能衰竭（如纽约心功能分级Ⅳ级、慢性肾衰竭尿毒症期、肝硬化失代偿期等）或恶性肿瘤晚期（预期生存期<6个月）者。 8. 存在严重感觉障碍（如患侧肢体深感觉完全缺失）、失语症（完全性运动性失语或混合性失语）或认知水平极低（MMSE评分<10分），无法理解指令并配合完成治疗及评估者。

Exclusion criteria：

1.Those with a history of head trauma (Glasgow Coma Scale score <= 12) or who have undergone head surgery; 2.Those with neurodegenerative diseases or episodic disorders such as Parkinson's disease, epilepsy (with a seizure history within the past 1 year), Alzheimer's disease, etc. that may independently cause cognitive impairment; 3. Those with implanted electronic medical devices (such as cardiac pacemakers, deep brain stimulators), brain metal foreign bodies (non-titanium alloy materials), or who have undergone ventriculoperitoneal shunt surgery; 4.Those wearing an artificial cochlea, having second-degree or higher atrioventricular conduction block, or experiencing acute asthma attacks; 5.Those whose standard parameters (stimulation intensity 80%-120% of the resting motor threshold) for repetitive transcranial magnetic stimulation on the motor area of the healthy or affected side fail to elicit motor evoked potentials (MEP); 6.Those who already have cognitive decline before a stroke or have been diagnosed with mental disorders (such as schizophrenia, severe depression) before; 7.Those with severe organ dysfunction (such as New York Heart Function Classification Grade IV, chronic renal failure uremic stage, liver cirrhosis decompensation stage, etc.) or advanced malignant tumors (expected survival period < 6 months); 8. Those with severe sensory disorders (such as complete loss of deep sensation in the affected limb), aphasia (complete motor aphasia or mixed aphasia), or extremely low cognitive level (MMSE score < 10), unable to understand instructions and cooperate to complete treatment and assessment.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2026-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-01 00:00:00 至 To 2026-01-31 00:00:00

干预措施：

Interventions：

组别：

taVNS治疗组

样本量：

 20

Group：

The taVNS treatment group

Sample size：

干预措施：

采用电子针疗仪，将耳夹电极固定于患者左侧耳廓的迷走神经耳部反射区（耳甲艇）。设置刺激参数：波形：双向、连续、非对称平衡波；频率5Hz，波宽200μs，电流强度调至患者耐受最大值（以无明显疼痛或不适为度）。20分钟/次/日，5d/周，持续3周。

干预措施代码：

Intervention：

Using an electronic acupuncture device, attach the ear clip electrode to the vagus nerve ear reflex area (the concha) on the left ear of the patient. Set the stimulation parameters: waveform: bidirectional, continuous, asymmetrical balanced wave; frequency 5Hz, pulse width 200μs, adjust the current intensity to the maximum level that the patient can tolerate (with no obvious pain or discomfort as the criterion). 20 minutes per session per day, 5 days per week, for 3 weeks.

Intervention code：

组别：

假刺激对照组

样本量：

 20

Group：

The sham stimulation control group

Sample size：

干预措施：

在常规康复训练基础上，予以假taVNS治疗。Sham-taVNS采用无触点电极，设备会显示电流读数，但实际并未产生电流。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation training, sham-taVNS treatment was administered using non-contact electrodes, which displayed current readings on the device but generated no actual current.

Intervention code：

组别：

同步治疗组

样本量：

 20

Group：

Synchronous treatment group

Sample size：

干预措施：

在常规康复训练基础上，实施taVNS与高频重复经颅磁刺激（HF-rTMS）同步治疗。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation training, taVNS and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) were implemented simultaneously for treatment.

Intervention code：

组别：

序贯治疗组（先中枢再外周组）

样本量：

 20

Group：

Sequential treatment group (central first, then peripheral)

Sample size：

干预措施：

在常规康复训练基础上，采用HF-rTMS与taVNS序贯治疗。先进行HF-rTMS治疗：操作及参数同同步治疗组的HF-rTMS部分，每次治疗20分钟；HF-rTMS治疗结束后，即刻启动taVNS治疗，操作及参数同taVNS组，每次治疗20分钟；每日1次（两次治疗连续完成），5d/周，共治疗3周。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation training, sequential treatment with HF-rTMS and taVNS was adopted. First, HF-rTMS treatment was carried out: the operation and parameters were the same as those of the HF-rTMS part in the synchronous treatment group, and each treatment lasted for 20 minutes; After the HF-rTMS treatment, taVNS treatment was immediately initiated, with the operation and parameters being the same as those of the taVNS group, and each treatment lasted for 20 minutes; It was performed once a day (with the two treatments completed consecutively), 5 times a week, for a total of 3 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 淮安 

Country：

China

Province：

Jiangsu

City：

Huai'an

单位(医院)：

 淮安市第二人民医院 

单位级别：

 三甲 

Institution
hospital：

Huaian Second People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

简易精神状态量表

指标类型：

主要指标

Outcome：

Mini-Mental State Examination,MMSE

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

蒙特利尔认知评估量表

指标类型：

主要指标

Outcome：

Montreal Cognitive Assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

洛文斯顿作业疗法认知评定

指标类型：

主要指标

Outcome：

Loewenstein Occupational Therapy Cognitive Assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

静息态功能性磁共振成像

指标类型：

主要指标

Outcome：

Resting-state functional magnetic resonance imaging

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究选取淮安市第二人民医院康复医学科住院治疗的卒中后认知障碍患者80例，采用随机数字表法将其分为四组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

In this study, 80 patients with post-stroke cognitive impairment who were hospitalized in the Rehabilitation Medicine Department of Huai'an Second People's Hospital were selected. They were randomly divided into four groups using a random number table method.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

患者和负责评估的医生均不清楚分组及治疗方案；治疗师知晓分组以实施干预，但不参与评估。

Blinding：

Neither the patients nor the doctors responsible for the assessment were aware of the groupings and treatment plans; the therapists were aware of the groupings to carry out the intervention, but did not participate in the assessment.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1. 采用SPSS 27.0统计学软件进行数据分析。计量资料以均数+/-标准差表示，多组间基线资料及干预后总体疗效比较采用单因素方差分析（ANOVA），组间两两比较采用 LSD-t 检验；相关性分析采用双变量 Pearson 检验；对四组患者治疗前后的认知功能指标（如 MMSE、MoCA、LOTCA评分）进行重复测量方差分析，以动态比较不同时间点的组内及组间差异。以P<=0.05为差异具有统计学意义。 2. 静息态fMRI数据使用MATLAB软件进行处理分析。为便于统计分析，使用MRIcro软件对受试者的功能参数图像（如后续分析的fALFF图、ReHo图）进行左、右翻转，使病灶均位于右侧大脑。rs-fMRI数据预处理使用RESTplus软件完成。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1. Data analysis was conducted using SPSS 27.0 statistical software. Measurement data were expressed as mean +/- standard deviation. Baseline data and overall therapeutic efficacy after intervention among multiple groups were compared using one-way analysis of variance (ANOVA), and pairwise comparisons between groups were performed using LSD-t test; correlation analysis was conducted using bivariate Pearson test; repeated measures analysis of variance was used to analyze the cognitive function indicators (such as MMSE, MoCA, LOTCA scores) of the four groups before and after treatment, to dynamically compare the intra-group and inter-group differences at different time points. A difference was considered statistically significant if P <= 0.05. 2. Resting-state fMRI data were processed and analyzed using MATLAB software. To facilitate statistical analysis, the functional parameter images of the subjects (such as the fALFF map and ReHo map for subsequent analysis) were flipped left and right using MRIcro software, so that the lesions were all located in the right brain. Preprocessing of rs-fMRI data was completed using RESTplus software.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-10-30 15:40:12
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