ChiCTR2600120381 版本V1.0 版本创建时间2026/03/13 09:06:28 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600120381 

最近更新日期：

Date of Last Refreshed on：

 2026-03-13 09:06:21 

注册时间：

Date of Registration：

 2026-03-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

双经皮耳迷走神经电刺激促进卒中后上肢运动功能的临床疗效和神经机制研究

Public title：

Clinical Efficacy and Neural Mechanisms of Bilateral Transcutaneous Auricular Vagus Nerve Stimulation in Promoting Upper Limb Motor Function Recovery After Stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

双经皮耳迷走神经电刺激促进卒中后上肢运动功能的临床疗效和神经机制研究

Scientific title：

Clinical Efficacy and Neural Mechanisms of Bilateral Transcutaneous Auricular Vagus Nerve Stimulation in Promoting Upper Limb Motor Function Recovery After Stroke

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：

吴敬蕾 

研究负责人：

许东升 

Applicant：

Wu Jinglei 

Study leader：

Xu Dongsheng 

申请注册联系人电话：

Applicant telephone：

 +86 135 2459 2521

研究负责人电话：

Study leader's
telephone：

+86 138 1710 3619

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：

 2931830495@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 dxu0927@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

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：

上海市浦东新区蔡伦路1200号

研究负责人通讯地址：

上海市浦东新区蔡伦路1200号

Applicant address：

1200 Cai Lun Road,Zhangjiang Hi-TechPark,Pudong New Area, Shanghai China

Study leader's address：

1200 Cai Lun Road,Zhangjiang Hi-TechPark,Pudong New Area, Shanghai 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：

上海中医药大学康复医学院

Applicant's institution：

School of Rehabilitation Science,Shanghai University of Traditional Chinese Medicine

研究负责人所在单位：

上海中医药大学附属岳阳中西医结合医院

Affiliation of the Leader：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

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：

 2026—009

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：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Yueyang Hospital Ethics Committee of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-02-05 00:00:00

伦理委员会联系人：

李旖旎

Contact Name of the ethic committee：

Li Yini

伦理委员会联系地址：

上海市浦东新区蔡伦路1200号

Contact Address of the ethic committee：

1200 Cai Lun Road,Zhangjiang Hi-TechPark,Pudong New Area, Shanghai China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 6516 1782

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：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市浦东新区蔡伦路1200号

Primary sponsor's address：

1200 Cai Lun Road,Zhangjiang Hi-TechPark,Pudong New Area, Shanghai 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)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京科技大学

具体地址：

北京市海淀区学院路30号

Institution
hospital：

University of Science and Technology Beijing

Address：

30 Xueyuan Road, Haidian District, Beijing, China

经费或物资来源：

中国国家重点研发计划资金（课题编号：2024YFF0507501；2024YFF05075012）

Source(s) of funding：

National Key R&D Program of China(Grand No.2024YFF0507501;2024YFF05075012)

研究疾病：

脑卒中  

Target disease：

stroke

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：

本研究将双侧耳迷走神经电刺激作为卒中后上肢障碍康复的干预方案，探索此干预方式对卒中患者上肢运动功能和运动学习能力的疗效，以及潜在的神经机制。  

Objectives of Study：

This study investigates the use of bilateral auricular vagus nerve stimulation as an intervention for upper limb impairment rehabilitation after stroke, aiming to explore its therapeutic effects on upper limb motor function and motor learning ability in stroke patients, as well as the underlying neural mechanisms.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）首次发病，单侧病灶，或者既往有发病史，但未遗留有明显的神经功能障碍; （2）患者年龄≥40周岁且≤80周岁，性别不限（以签署知情同意书当天为准）； （3）病程为6个月-18个月； （4）存在上肢运动功能障碍，Brunnstrom分期在Ⅲ—Ⅵ期； （5）认知情况良好，MMSE评分＞21分，能够配合完成评估及训练； （6）患者及家属签署知情同意书，自愿参加本研究。

Inclusion criteria

1. First-ever stroke, with unilateral lesions, or a history of previous stroke but without significant neurological deficits; 2. Patients aged >= 40 years and <= 80 years, regardless of gender (based on the date of signing the informed consent form); 3. Disease duration between 6 months and 18 months; 4. Presence of upper limb motor dysfunction, with Brunnstrom stage ranging from III to VI; 5. Good cognitive function, with a Mini-Mental State Examination (MMSE) score > 21, and ability to cooperate with assessments and training; 6. Patients and their family members sign the informed consent form and voluntarily participate in this study.

排除标准：

（1）既往接受过迷走神经手术； （2）佩戴心脏起搏器或其他植入式电子设备； （3）存在严重的心血管系统疾病，或者肺、肝、肾功能不全者； （4）存在除卒中以外其他导致上肢功能障碍的病因； （5）服用精神类药物，有精神疾病史、癫痫史者； （6）窦性心动过缓(心率<60次/min)； （7）处于妊娠期、哺乳期妇女或近期计划备孕的患者。

Exclusion criteria：

1. Previous history of vagus nerve surgery; 2. Use of a cardiac pacemaker or other implantable electronic devices; 3. Presence of severe cardiovascular disease, or pulmonary, hepatic, or renal insufficiency; 4. Presence of other causes of upper limb dysfunction unrelated to stroke; 5. Use of psychiatric medications, or a history of mental illness or epilepsy; 6. Symptomatic bradycardia (heart rate < 60 bpm); 7. Women who are pregnant, breastfeeding, or planning pregnancy in the near future.

研究实施时间：

Study execute time：

从 From 2026-02-05 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-01 00:00:00 至 To 2027-02-05 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 22

Group：

Experimental group

Sample size：

干预措施：

双侧耳迷走神经电刺激+常规康复。 双侧耳迷走神经电刺激：使用双耳同步迷走神经电刺激仪（江西精一科技）设备，参数：25Hz方波，脉宽200μs，刺激时间30s，通断比1∶1，共刺激20分钟；电流强度调整为患者所能耐受的最大刺激强度，但不超过10mA；使用前，用酒精棉球擦拭患者左右耳的耳甲艇区；将左右两个入耳式电极的触点分别置于并紧贴左、右耳甲艇区，患者处于坐位，即可开始刺激。1日1次，共进行5次，每次20分钟。 常规康复：依据《中国脑卒中早期康复治疗指南》进行常规康复治疗，包括良肢位摆放、手法治疗（如肌张力放松、关节松动术、关节被动活动等）、肌力训练、精细动作训练、作业活动训练等。1日1次，共进行5次，每次20分钟。

干预措施代码：

Intervention：

Bilateral Transcutaneous Auricular Vagus Nerve Stimulation + Conventional Rehabilitation Bilateral Transcutaneous Auricular Vagus Nerve Stimulation: The bilateral synchronous auricular vagus nerve stimulation device was used with the following parameters: 25 Hz square wave, pulse width 200 μs, stimulation duration 30 s, on-off ratio 1:1, total stimulation time 20 min. The current intensity was adjusted to the maximum level tolerable to the patient, but did not exceed 10 mA. Before each session, the cymba concha area of both ears was wiped with an alcohol swab. The contacts of the two in-ear electrodes were placed and pressed against the left and right cymba concha areas respectively, with the patient in a seated position, after which stimulation was initiated. The intervention was administered once daily for a total of 5 sessions, each lasting 20 minutes. Conventional Rehabilitation: Conventional rehabilitation was conducted in accordance with the Guidelines for Early Stroke Rehabilitation in China, including positioning in a functional position, manual therapy (e.g., muscle tone relaxation, joint mobilization, passive range of motion exercises), muscle strength training, fine motor training, and occupational activity training. The intervention was administered once daily for a total of 5 sessions, each lasting 20 minutes.

Intervention code：

组别：

对照组

样本量：

 22

Group：

Control group

Sample size：

干预措施：

双侧耳迷走神经电刺激伪刺激+常规康复。 双侧耳迷走神经电刺激伪刺激：设备、参数、流程与真刺激一致，但在入耳式电极的触点处做绝缘处理，将电极置于耳道内，不接触耳甲艇区。1日1次，共进行5次，每次20分钟。 常规康复：依据《中国脑卒中早期康复治疗指南》进行常规康复治疗，包括良肢位摆放、手法治疗（如肌张力放松、关节松动术、关节被动活动等）、肌力训练、精细动作训练、作业活动训练等。1日1次，共进行5次，每次20分钟。

干预措施代码：

Intervention：

Sham Stimulation of Bilateral Transcutaneous Auricular Vagus Nerve Stimulation + Conventional Rehabilitation Sham Stimulation of Bilateral Transcutaneous Auricular Vagus Nerve Stimulation: The device, parameters, and procedure were identical to those used in the experimental group, except that the contacts of the in-ear electrodes were insulated, and the electrodes were placed in the ear canal without contacting the cymba concha area. The intervention was administered once daily for a total of 5 sessions, each lasting 20 minutes. Conventional Rehabilitation: Conventional rehabilitation was conducted in accordance with the Guidelines for Early Stroke Rehabilitation in China, including positioning in a functional position, manual therapy (e.g., muscle tone relaxation, joint mobilization, passive range of motion exercises), muscle strength training, fine motor training, and occupational activity training. The intervention was administered once daily for a total of 5 sessions, each lasting 20 minutes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海中医药大学附属岳阳中西医结合医院 

单位级别：

 三甲 

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

手部灵巧度

指标类型：

主要指标

Outcome：

Hand dexterity

Type：

Primary indicator

测量时间点：

测量方法：

积木盒障碍测试评估

Measure time point of outcome：

Measure method：

Box and Block Test, BBT

指标中文名：

序列反应时间

指标类型：

次要指标

Outcome：

Serial Reaction Time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

上肢运动功能

指标类型：

次要指标

Outcome：

Upper limb motor function

Type：

Secondary indicator

测量时间点：

测量方法：

普渡钉板测验

Measure time point of outcome：

Measure method：

Purdue Pegboard Test, PPT

指标中文名：

上肢Fugl-Meyer运动功能

指标类型：

次要指标

Outcome：

Fugl-Meyer Assessment - Upper Extremity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电图数据

指标类型：

次要指标

Outcome：

EEG Data

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心率

指标类型：

附加指标

Outcome：

Heart Rate per Minute

Type：

Additional 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

 其它  

说明

Fate of sample：

0thers  

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 40 岁 years
最大 Max age 80 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）：

随机化程序由独立统计学家（未参与研究的开展）执行。采用计算机生成的随机数字表，将符合纳入标准的脑卒中患者，按照1:1的比例随机分至两组：对照组和试验组。以此确保每组有22名受试者参与。

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

The randomization procedure was performed by an independent statistician who was not involved in the implementation of the study. A computer-generated random number table was used to assign eligible stroke patients in a 1:1 ratio to either the control group or the experimental group, ensuring that 22 participants were allocated to each group.

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：

受试者不会被告知自己被分配至试验组还是对照组。所有刺激设备在外观、操作、声音、初始皮肤感觉上完全一致。研究者因需操作设备，无法完全对干预目标分配情况保持盲法。因此，我们将针对受试者、负责数据收集以及最终统计分析的评估人员和统计人员，实施盲法。

Blinding：

The participants were not informed of whether they were assigned to the experimental group or the control group. All stimulation devices were completely identical in appearance, operation, sound, and initial skin sensation. Due to the need to operate the equipment, the researchers could not be completely masked to group allocation. Therefore, masking was implemented for the participants, the evaluators responsible for data collection, and the statisticians responsible for the final statistical analysis.

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)：

N/A

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：

由独立的评估人员在评估过程中、研究人员在试验过程记录病例记录表（CRF表），保留记录时间和人员签名；由独立的数据分析人员设计符合研究需求的电子化数据录入表单，由研究人员及时录入数据，并记录电子签名；数据分析人员将在过程中监察数据质量，最后进行统计分析。

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

The case report forms (CRFs) were completed by independent evaluators during the assessment process and by researchers during the trial procedure, with the recording time and the signatures of the personnel retained. An electronic data entry form tailored to the research requirements was designed by an independent data analyst, and data were entered by the researchers in a timely manner, accompanied by electronic signatures. The data analyst monitored data quality throughout the process and ultimately performed the statistical analysis.

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：

  2026-03-13 09:06:21