ChiCTR2500113367 版本V1.0 版本创建时间2025/11/27 11:40:05 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：

 ChiCTR2500113367 

最近更新日期：

Date of Last Refreshed on：

 2025-11-27 11:40:00 

注册时间：

Date of Registration：

 2025-11-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

精准定位下爆发式经颅磁刺激治疗卒中后 皮质下失语的研究

Public title：

A study of precise targeted burst transcranial stimulation in the treatment of subcortical post-stroke aphasia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

精准定位下爆发式经颅磁刺激治疗卒中后皮质下失语的研究

Scientific title：

A study of precise targeted burst transcranial stimulation in the treatment of subcortical post-stroke aphasia

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：

张小年 

研究负责人：

王小乙;张小年 

Applicant：

Zhang Xiaonian 

Study leader：

Wang Xiaoyi;Zhang Xiaonian 

申请注册联系人电话：

Applicant telephone：

 +86 136 5137 6101

研究负责人电话：

Study leader's
telephone：

+86 136 5137 6101

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：

 youthzxn@163.com

研究负责人电子邮件：

Study leader's E-mail：

 youthzxn@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：

北京市丰台区角门北路10号

研究负责人通讯地址：

北京市丰台区角门北路10号

Applicant address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

Study leader's address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

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：

中国康复研究中心

Applicant's institution：

China Rehabilitation Research Center

研究负责人所在单位：

中国康复研究中心

Affiliation of the Leader：

China Rehabilitation Research Center

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：

 2025-040-02

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：

中国康复研究中心伦理委员会

Name of the ethic committee：

Ethics Committee of China Rehabilitation Research Center

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-06 00:00:00

伦理委员会联系人：

孟丽君

Contact Name of the ethic committee：

Meng Lijun

伦理委员会联系地址：

北京市丰台区角门北路10号

Contact Address of the ethic committee：

No. 10, Jiaomen North Road, Fengtai District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8756 8812

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：

中国康复研究中心

Primary sponsor：

China Rehabilitation Research Center

研究实施负责（组长）单位地址：

北京市丰台区角门北路10号

Primary sponsor's address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

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)：

中国康复研究中心

具体地址：

北京市丰台区角门北路10号

Institution
hospital：

China Rehabilitation Research Center

Address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

经费或物资来源：

中央级公益性科研院所基本科研业务费专项资金

Source(s) of funding：

Special funds for basic scientific research business expenses of central public welfare scientific research institutes

研究疾病：

卒中；失语  

Target disease：

Stroke;aphasia

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：

寻找基于个体化功能-结构特征的精准靶点定位方法；构建客观的疗效预测标志物；探索语言网络功能连接强度变化能否预测 WAB 评分改善；  

Objectives of Study：

To find an accurate target localization method based on individualized function-structure characteristics. constructing objective efficacy prediction markers; To explore whether changes in the functional connection strength of language networks can predict the improvement of WAB scores.

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.患者年龄为45 岁以上（包括45岁）； 2.符合急性缺血性脑卒中的诊断标准（采用 2019 年美国心脏协会/美国卒 中协会编写《Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke》及 2018 年中华医学会神经病 学分会 编写的《中国急性缺血性脑卒中诊治指南 2018》进行诊断），病灶均在左侧半球， 病程大于等于3个月，小于等于1年； 3.根据中文版西部失语症检查量表(WAB)评定为失语症患者， WAB 失语商小于93.8 分； 4.首次发病，或曾经发病无明显后遗症(本次卒中前改良 Rankin 量表评分（mRS）<=1 分)； 5.发病前语言功能正常，且母语为汉语，小学以上文化（受过 6 年以上教育）； 6.了解试验并签署知情同意书。

Inclusion criteria

1.The patient is 45 years old or above (including 45 years old). 2. Meet the diagnostic criteria for Acute ischemic stroke (using the Guidelines for the Early Management of Patients With Acute written by the American Heart Association/American Stroke Association in 2019 Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke and the Neurology Branch of the Chinese Medical Association in 2018 The diagnosis was made in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018". The lesions were all in the left hemisphere, and the disease course was greater than or equal to 3 months and less than or equal to 1 year. 3. According to the Chinese version of the Western Aphasia Checklist (WAB), the patient was assessed as having aphasia, with an WAB aphasia quotient of less than 93.8 points. 4. First onset, or previous onset without obvious sequelae (modified Rankin Scale (mRS) score before this stroke <=1 point); 5. Before the onset of the disease, the language function was normal, and the native language was Chinese, with a primary school education or above (having received more than 6 years of education). 6. Understand the trial and sign the informed consent form.

排除标准：

1.合并有严重的构音障碍者（NIHSS 第 10 项构音项>=2 分） ； 2.存在脑肿瘤、帕金森综合症、运动神经元病、脑出血、脑外伤等其他疾病导致的失语； 3.装有心脏起搏器、人工耳蜗或其他金属异物及植入体内的任何电子装备者、存在幽闭恐惧症等MRI扫描禁忌症、TMS治疗禁忌症； 4.合并癫痫病史（存在至少 2 次间隔超过 24h 的非诱发的癫痫发作，或诊断为癫痫综合征，或在过去12个月内有癫痫发作） ； 5.经实验室检验、检查发现合并有严重心、肺、肝、肾等系统性疾病且常规用药无法控制的患者； 6.合并意识障碍（NIHSS 1(a)项>=1 分）的患者； 7.合并恶性高血压（血压突然显著升高，收缩压、舒张压均增高，常持续在200/130mmHg 以上） ； 8.合并恶性肿瘤的患者； 9.卒中以外的其他原因导致预期寿命小于1年患者； 10.合并耳聋、视觉障碍、严重认知障碍等以至无法配合试验者； 11.存在严重抑郁、焦虑状态，或诊断有其他精神疾病以致无法配合完成试验的患者； 12.入组前3个月接受过TMS、经颅电刺激等其他神经调控治疗者； 13.存在合并酒精酗酒、药物等滥用史； 14.存在其他检查异常研究者判断不适合参与此试验的患者； 15.怀孕或计划怀孕的育龄期妇女； 16.正在参加其他临床研究试验者。

Exclusion criteria：

1. Those with severe articulation disorders (NIHSS articulation item 10 >=2 points); 2. Aphasia caused by other diseases such as brain tumors, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, and brain trauma; 3. Individuals with cardiac pacemakers, cochlear implants or other metal foreign bodies, or any electronic devices implanted in the body, those with claustrophobia or other contraindications for MRI scans, and those with contraindications for TMS treatment; 4. History of epilepsy (at least two non-induced epileptic seizures with an interval of more than 24 hours, or diagnosed with epilepsy syndrome, or having epileptic seizures within the past 12 months); 5. Patients who have been found to have severe systemic diseases such as heart, lung, liver and kidney through laboratory tests and examinations and whose conditions cannot be controlled by conventional medication; 6. Patients with combined consciousness disorders (NIHSS item 1(a) >=1 point); 7. Combined with malignant hypertension (sudden and significant increase in blood pressure, with both systolic and diastolic blood pressures elevated, often remaining above 200/130 MMHG); 8. Patients with concurrent malignant tumors; 9. Patients whose life expectancy is less than one year due to reasons other than stroke; 10. Those with combined deafness, visual impairment, severe cognitive impairment, etc., to the extent that they are unable to cooperate with the experiment; 11. Patients who are in a state of severe depression or anxiety, or have been diagnosed with other mental disorders that prevent them from cooperating to complete the trial; 12. Those who have received other neuroregulation treatments such as TMS and transcranial electrical stimulation in the 3 months prior to enrollment; 13. There is a history of concurrent alcohol abuse, drug abuse, etc. 14. Patients who have other abnormal examination results and are judged by the researchers as unsuitable for participating in this trial; 15. Women of childbearing age who are pregnant or planning to become pregnant; 16. Those who are participating in other clinical research trials.

研究实施时间：

Study execute time：

从 From 2025-11-20 00:00:00至 To 2026-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-30 00:00:00 至 To 2026-12-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 10

Group：

Experimental Group

Sample size：

干预措施：

基于静息态fMRI和DTI排除无效区域，参数:90%RUT，丛内频率50Hz，丛内脉冲3个，丛间频率5Hz; 剂量与疗程:每天一次，每次治疗为丛内频率50Hz，丛内脉冲3,丛间频率5Hz，丛内个数10,重复20次,问歇8s,脉冲总数600,刺激时间200s，连续21天(共3 周)

干预措施代码：

Intervention：

Based on the exclusion of ineffective regions by resting-state fMRI and DTI, parameters :90%RUT, intra-plexus frequency 50Hz, 3 intra-plexus pulses, inter-plexus frequency 5Hz; Dosage and treatment course: Once a day. Each treatment session consists of an intraplexus frequency of 50Hz, 3 intraplexus pulses, an interplexus frequency of 5Hz, 10 intraplexus pulses, repeated 20 times, with an 8-second break, a total of 600 pulses, and an stimulation time of 200s. This lasts for 21 consecutive days (a total of 3 weeks).

Intervention code：

组别：

对照组

样本量：

 10

Group：

Control group

Sample size：

干预措施：

参数:90%RUT，丛内频率50Hz，丛内脉冲3个，丛间频率5Hz; 剂量与疗程:每天一次，每次治疗为丛内频率50Hz，丛内脉冲3,丛间频率5Hz，丛内个数10,重复20次,问歇8s,脉冲总数600,刺激时间200s，连续21天(共3 周)

干预措施代码：

Intervention：

parameters: 90% RUT, intraplex frequency 50Hz, 3 intraplex pulses, interplexic frequency 5Hz; Dosage and duration: Once a day, each treatment is intraplexic frequency 50Hz, intraplexic pulse 3, interplexic frequency 5Hz, intraplexic number 10, 20 repetitions, intermediate 8s, total pulse 600, stimulation time 200s, 21 consecutive days (3 weeks in total)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国康复研究中心 

单位级别：

 三甲 

Institution
hospital：

China Rehabilitation Research Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

西方失语症成套测验

指标类型：

主要指标

Outcome：

Western Aphasia Test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗前后的脑功能连接、结构连接改变

指标类型：

主要指标

Outcome：

Changes in brain functional and structural connections before and after treatment

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

 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 45 岁 years
最大 Max age 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）：

由研究参与者凌子锐使用计算机SPSS生成随机数字表

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

A random number table was generated by study participant Ling Zirui using computer SPSS

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：

本试验采用双盲设计，对受试者、受试者家属及看护人员、招募者、临床医护人员、评估者、数据采集及统计分析者实施盲法。以上人员不会知晓患者的分组情况。

Blinding：

This trial adopts a double-blind design, blinding subjects, subjects' families and caregivers, recruiters, clinical care staff, evaluators, data collection and statistical analysts. The above personnel will not know the grouping of the patients.

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-11-27 11:40:00