简体中文|English
Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Efficacy of Repetitive Transcranial Magnetic Stimulation Combined with Virtual Reality Scenario Training in Patients with Post-Stroke Dysphagia

download

注册号：

Registration number：

ChiCTR2600120665 

最近更新日期：

Date of Last Refreshed on：

2026-03-18 10:12:35 

注册时间：

Date of Registration：

2026-03-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

重复经颅磁刺激结合虚拟场景训练在脑卒中后吞咽障碍患者中的疗效研究

Public title：

Efficacy of Repetitive Transcranial Magnetic Stimulation Combined with Virtual Reality Scenario Training in Patients with Post-Stroke Dysphagia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重复经颅磁刺激结合虚拟场景训练在脑卒中后吞咽障碍患者中的疗效研究

Scientific title：

Efficacy of Repetitive Transcranial Magnetic Stimulation Combined with Virtual Reality Scenario Training in Patients with Post-Stroke Dysphagia

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：

孙佳琳 

研究负责人：

覃亮 

Applicant：

Jialin Sun 

Study leader：

Liang Qin 

申请注册联系人电话：

Applicant telephone：

+86 156 1358 3682

研究负责人电话：

Study leader's telephone：

+86 150 3022 8082

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：

sjl010329@163.com

研究负责人电子邮件：

Study leader's E-mail：

ygt1907@126.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：

河北省保定市莲池区裕华东路212号

研究负责人通讯地址：

河北省保定市莲池区裕华东路212号

Applicant address：

No. 212, Yuhua Donglu, Lianchi District, Baoding City, Hebei Province, China

Study leader's address：

No. 212, Yuhua Donglu, Lianchi District, Baoding City, Hebei 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：

河北大学

Applicant's institution：

Hebei University

研究负责人所在单位：

河北大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Hebei University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

HDFYLL-IIT-2025-074

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：

河北大学附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of Hebei University Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-18 00:00:00

伦理委员会联系人：

柏金秀

Contact Name of the ethic committee：

Jinxiu Bai

伦理委员会联系地址：

河北省保定市莲池区裕华东路212号

Contact Address of the ethic committee：

No. 212, Yuhua Donglu, Lianchi District, Baoding City, Hebei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 312 598 1513

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：

河北大学附属医院

Primary sponsor：

Affiliated Hospital of Hebei University

研究实施负责（组长）单位地址：

河北省保定市莲池区裕华东路212号

Primary sponsor's address：

No. 212, Yuhua Donglu, Lianchi District, Baoding City, Hebei 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)：

河北省

市(区县)：

保定市

Country：

China

Province：

Hebei

City：

Baoding

单位(医院)：

河北大学附属医院

具体地址：

河北省保定市莲池区裕华东路212号

Institution
hospital：

Affiliated Hospital of Hebei University

Address：

No. 212, Yuhua Donglu, Lianchi District, Baoding City, Hebei Province, China

经费或物资来源：

课题经费

Source(s) of funding：

Project Funding

Target disease：

Post-stroke dysphagia (PSD)

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本课题从临床诊疗实践出发，采用前瞻性随机对照研究方法，以脑卒中后吞咽障碍患者为主要研究对象，拟通过临床观察： （1）探索重复经颅磁刺激结合虚拟场景训练改善吞咽障碍患者的吞咽功能的疗效，提高训练有效性及依从性的临床价值，为治疗提供新的思路。 （2）在常规量表评估及吞咽造影评估基础上，增加表面肌电图评估患者吞咽肌群力量及静息态功能磁共振评估在不同治疗方式下脑功能变化。分析该疗法对患者脑功能影响，了解患者病灶部位对患者预后的影响及治疗后疗效机制分析。 （3）规范吞咽障碍康复治疗方案及全面的评估方法，为临床吞咽障碍的治疗提供数据基础。  

Objectives of Study：

This project is grounded in clinical practice and adopts a prospective randomized controlled study design, focusing on patients with post-stroke dysphagia. Through clinical observation, it aims to: (1) Investigate the therapeutic efficacy of repetitive transcranial magnetic stimulation combined with virtual scenario training in improving swallowing function in dysphagia patients, and explore its clinical value in enhancing training effectiveness and compliance, thereby providing new insights for treatment. (2) Supplement conventional scale assessments and videofluoroscopic swallowing studies with surface electromyography to evaluate the strength of swallowing muscles and resting-state functional magnetic resonance imaging to assess cerebral functional changes under different treatment modalities. This will allow analysis of the therapy's impact on cerebral function, understanding of the influence of lesion location on patient prognosis, and exploration of the mechanisms underlying therapeutic effects. (3) Standardize rehabilitation treatment protocols and comprehensive assessment methods for dysphagia, providing a data-driven foundation for clinical management of swallowing disorders.

药物成份或治疗方案详述：

本研究纳入60例脑卒中后吞咽障碍患者，采用随机数字表，将符合纳入标准的患者随机分为三组，均给予常规治疗，包括：口颜面主被动肌力训练、冰刺激训练、针刺、吞咽低频电刺激等常规治疗，在此基础上A组增加重复经颅磁刺激治疗（根据患者影像学检查，计算刺激靶点，作用于双侧大脑半球下颌舌骨肌运动皮层代表区，治疗师定位靶点，设定参数，矫正校准，给予5Hz rTMS和3Hz rTMS，时间40s），B组增加吞咽虚拟场景训练（视觉、触觉、嗅觉刺激训练，如根据患者既往饮食习惯，给予患者感兴趣的食物，让患者用肢体触摸、嗅触及注视患者家属进食过程，促进患者主动性吞咽动作产生），C组增加重复经颅磁刺激结合吞咽虚拟场景训练（重复经颅磁刺激后半小时内给予吞咽虚拟场景训练）。疗程：治疗时间为每天1次，共28天。 

Description for medicine or protocol of treatment in detail：

This study enrolled 60 patients with post‑stroke dysphagia. Using a random number table, eligible patients were randomly assigned to three groups. All groups received conventional treatment, including: active and passive orofacial muscle strength training, ice‑stimulation training, acupuncture, and low‑frequency electrical stimulation for swallowing. On this basis: Group A received additional repetitive transcranial magnetic stimulation (rTMS). Based on the patient's imaging data, the stimulation target was calculated and applied to the bilateral cortical representation of the mylohyoid muscle in the motor cortex. The therapist located the target, set parameters, performed calibration, and administered 5 Hz rTMS and 3 Hz rTMS, each for 40 seconds. Group B received additional swallowing virtual scenario training. This involved visual, tactile, and olfactory stimulation training—for example, presenting foods of interest according to the patient’s previous dietary habits, allowing the patient to touch, smell, and observe family members eating, thereby promoting active swallowing movements. Group C received both repetitive transcranial magnetic stimulation combined with swallowing virtual scenario training (virtual scenario training was provided within half an hour after rTMS). The treatment course consisted of one session daily for a total of 28 days. 

纳入标准：

脑卒中后吞咽障碍患者，病程1-2个月，年龄在38-80岁之间，洼田饮水试验4-5级；经头颅CT或MRI确诊且无颅骨缺损；预期入院时间≥28d。

Inclusion criteria

Patients with post-stroke dysphagia, disease duration of 1–2 months, aged between 38 and 80 years, with a Kubota Water Swallowing Test grade of 4–5; confirmed by cranial CT or MRI without skull defect; and an expected length of hospital stay of >=28 days.

排除标准：

其他原因(脑外伤、脑十卒中等)引起的吞咽障碍；体内有金属植入；吞咽结构异常；患有心脏、肝脏、肺脏等重要器官疾病或恶性肿瘤；有癫痫发作病史。

Exclusion criteria：

Dysphagia caused by other conditions (such as traumatic brain injury, stroke, etc.); presence of metal implants in the body; structural abnormalities of the swallowing organs; severe diseases of vital organs (e.g., heart, liver, lungs) or malignant tumors; and history of epileptic seizures.

研究实施时间：

Study execute time：

从 From 2025-06-18 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-20 00:00:00 至 To 2026-12-01 00:00:00  

干预措施：

Interventions：

组别：

A组

样本量：

20

Group：

Group A

Sample size：

干预措施：

在常规治疗（包括口颜面主被动肌力训练、冰刺激训练、针刺、吞咽低频电刺激等）基础上，A组患者增加重复经颅磁刺激治疗。刺激靶点依据神经影像学定位双侧大脑半球下颌舌骨肌运动皮层代表区，采用5 Hz及3 Hz rTMS，每次刺激持续40秒。治疗每日1次，共28天。

干预措施代码：

Intervention：

On the basis of conventional therapy (including active/passive orofacial muscle training, ice stimulation training, acupuncture, and low-frequency electrical stimulation for swallowing), patients in Group A additionally received repetitive transcranial magnetic stimulation. The stimulation targeted the bilateral cortical representations of the mylohyoid muscle in the motor cortex, as localized via neuroimaging. The protocol consisted of 5 Hz and 3 Hz rTMS, with each session lasting 40 seconds. The intervention was administered once daily for a total of 28 days.

Intervention code：

组别：

B组

样本量：

20

Group：

Group B

Sample size：

干预措施：

在常规治疗（包括口颜面主被动肌力训练、冰刺激训练、针刺、吞咽低频电刺激等）基础上，B组患者增加基于虚拟现实的多感觉整合吞咽训练。训练融合视觉、触觉及嗅觉刺激，并根据患者饮食偏好进行个性化场景设置，如接触、嗅闻感兴趣的食物，观察家人进食以诱发主动吞咽。训练每日1次，共28天。

干预措施代码：

Intervention：

On the basis of conventional therapy (including active/passive orofacial muscle training, ice stimulation training, acupuncture, and low-frequency electrical stimulation for swallowing), patients in Group B additionally underwent virtual reality-based swallowing training with multisensory integration. The training incorporated visual, tactile, and olfactory stimulation, with scenarios personalized according to patients’ dietary preferences—such as interacting with and smelling preferred foods, and observing family members during meals to elicit voluntary swallowing. The training was conducted once daily for 28 days.

Intervention code：

组别：

C组

样本量：

20

Group：

Group C

Sample size：

干预措施：

在常规治疗（包括口颜面主被动肌力训练、冰刺激训练、针刺、吞咽低频电刺激等）基础上，C组患者接受重复经颅磁刺激与虚拟场景训练的联合干预。rTMS方案与A组相同，虚拟场景训练方案与B组相同，且虚拟训练在rTMS治疗后30分钟内进行。联合干预每日1次，共28天。

干预措施代码：

Intervention：

On the basis of conventional therapy (including active/passive orofacial muscle training, ice stimulation training, acupuncture, and low-frequency electrical stimulation for swallowing), patients in Group C additionally received a combined intervention of rTMS and virtual scenario training. The rTMS protocol was identical to that of Group A, and the virtual training protocol was identical to that of Group B, with the virtual training administered within 30 minutes after rTMS. The combined intervention was delivered once daily over 28 days.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

 保定市 

Country：

China 

Province：

HeBei Province 

City：

Baoding 

单位(医院)：

河北大学附属医院 

单位级别：

三甲 

Institution
hospital：

Affiliated Hospital Of Hebei University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

吞咽造影检查

指标类型：

主要指标

Outcome：

Videofluoroscopic Swallowing Study,VFSS

Type：

Primary indicator

测量时间点：

治疗前、治疗28天后

测量方法：

采用东芝平板数字胃肠机（MFX-8000A）进行吞咽造影检查，动态观察吞咽过程中口腔期、咽期、食管期的结构与功能变化。

Measure time point of outcome：

Before treatment, after 28 days of treatment

Measure method：

Videofluoroscopic swallowing study performed using Toshiba flat-panel digital gastrointestinal machine (MFX-8000A) to dynamically observe structural and functional changes during oral, pharyngeal, and esophageal phases of swallowing.

指标中文名：

表面肌电图检查

指标类型：

主要指标

Outcome：

Surface electromyography,sEMG

Type：

Primary indicator

测量时间点：

治疗前、治疗28天后

测量方法：

使用表面肌电图设备记录舌骨上下肌群的肌电信号，分析肌肉活动的幅度、时序及协调性参数。

Measure time point of outcome：

Before treatment, after 28 days of treatment

Measure method：

Surface electromyography device is used to record electromyographic signals from swallowing-related muscles (e.g., submental muscles, infrahyoid muscles), analyzing amplitude, timing, and coordination parameters of muscle activity.

指标中文名：

静息态功能磁共振

指标类型：

主要指标

Outcome：

Resting-state functional Magnetic Resonance Imaging, rs-fMRI

Type：

Primary indicator

测量时间点：

治疗前、治疗28天后

测量方法：

使用西门子MAGNETOM Amira 1.5T功能磁共振设备，采集静息态血氧水平依赖信号，采用低频振幅分析方法，衡量各脑区在低频震荡下的信号强度变化，分析治疗前后脑功能连接与可塑性的改变。

Measure time point of outcome：

Before treatment, after 28 days of treatment

Measure method：

Using Siemens MAGNETOM Amira 1.5T functional MRI equipment to collect resting-state blood oxygen level-dependent signals. Amplitude of low-frequency fluctuations analysis method is employed to measure changes in signal intensity under low-frequency oscillations across brain regions, analyzing alterations in brain functional connectivity and plasticity before and after treatment.

指标中文名：

洼田饮水试验

指标类型：

次要指标

Outcome：

Water Swallowing Test

Type：

Secondary indicator

测量时间点：

治疗前、治疗14天、治疗28天

测量方法：

患者取端坐或半卧位，嘱其在无呛咳的情况下一次性喝下30毫升温开水，观察并记录完成饮水所需的时间及呛咳情况，依据标准分级（1-5级）评估吞咽障碍的安全程度。

Measure time point of outcome：

Before treatment, 14 days of treatment, 28 days of treatment

Measure method：

The patient is instructed to sit upright or in a semi-recumbent position and drink 30ml of warm water in one go without choking. The time required to complete the drinking task and the presence of coughing are observed and recorded. The safety of swallowing function is assessed according to the standard grading scale (Level 1-5).

指标中文名：

V-VST评估

指标类型：

次要指标

Outcome：

Volume-Viscosity Swallow Test Assessment

Type：

Secondary indicator

测量时间点：

治疗前、治疗14天、治疗28天

测量方法：

采用不同容量（5ml, 10ml）及稠度（稀流质、浓流质、糊状）的食团，在电视荧光屏或直接观察下进行吞咽测试，以评估患者吞咽不同性状食物的安全性（有无呛咳、音质改变等）与有效性（有无食物残留）。

Measure time point of outcome：

Before treatment, 14 days of treatment, 28 days of treatment

Measure method：

A swallow test using food boluses of different volumes (5ml, 10ml) and consistencies (thin liquid, thick liquid, paste) is conducted under videofluoroscopic or direct observation. It assesses the safety (presence of coughing, voice change) and efficacy (presence of residue) of the patient's swallow with different food textures.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

No

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 38 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）：

使用随机数字表法。（由一名不参与临床治疗与结局评估的统计人员负责，使用SPSS 26.0软件生成1到60的随机数字序列，按 1:1:1 的比例随机分为三组，分别是A组（重复经颅磁刺激组）、B组（虚拟场景训练组）、C组（联合治疗组）

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

Using a random number table method, a statistician not involved in clinical treatment or outcome assessment generated a random number sequence from 1 to 60 using SPSS 26.0 software. The participants were then randomly divided into three groups in a 1:1:1 ratio: Group A (repetitive transcranial magnetic stimulation group), Group B (virtual scenario training group), and Group C (combination therapy group).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究采用结局评估者盲法，所有参与疗效评价的研究人员（如进行洼田饮水试验、V-VST评估的言语治疗师，操作吞咽造影、表面肌电图和功能核磁的影像/康复技师）均不参与分组过程，且对患者的分组情况不知情。数据录入与统计分析阶段也采用盲法处理，数据交由不知晓分组情况的统计人员进行分析。

Blinding：

This study employed outcome assessor blinding. All researchers involved in the efficacy evaluation, including the speech therapists who performed the water swallowing test and the Volume-Viscosity Swallow Test (V-VST), as well as the imaging/rehabilitation technicians who conducted the videofluoroscopic swallowing study, surface electromyography, and functional magnetic resonance imaging, were unaware of the group assignments and did not participate in the allocation process. Blinding was also maintained during the data entry and statistical analysis phases, with the data being analyzed by a statistician who was blinded to the group allocation.

是否共享原始数据：

IPD sharing

Yes

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）：

ResMan,论文发表后一年内， http://www.medresman.org.cn/login.aspx。

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

ResMan, within one year of publication, http://www.medresman.org.cn/login.aspx.

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：

数据量表及病例采集由医院电子采集系统管理

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

Data forms and case data collection were managed via the hospital's electronic data capture system.

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：

  2026-03-18 10:12:18
return list
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

Chinese Clinical Trial Registry, Primary Registry of WHO International Clinical Trials Registry Platform

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. Chinese Clinical Trial Registry

蜀ICP备16010396号-9

Note: It is recommended to use the widescreen display resolution of Internet Explorer 8.0 or later