ChiCTR2500107839 版本V1.0 版本创建时间2025/08/19 17:31:53 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：

 ChiCTR2500107839 

最近更新日期：

Date of Last Refreshed on：

 2025-08-19 17:31:43 

注册时间：

Date of Registration：

 2025-08-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

不同靶点重复经颅磁刺激对脑卒中后失语症患者语言康复的对比研究

Public title：

A comparative study of different target repetitive transcranial magnetic stimulation on language rehabilitation in patients with aphasia after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同靶点重复经颅磁刺激对脑卒中后失语症患者语言康复的对比研究

Scientific title：

A comparative study of different target repetitive transcranial magnetic stimulation on language rehabilitation in patients with aphasia 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：

闫华 

研究负责人：

刘睿 

Applicant：

Yan Hua 

Study leader：

Liu Rui 

申请注册联系人电话：

Applicant telephone：

 +86 152 0246 3225

研究负责人电话：

Study leader's
telephone：

+86 150 0299 5399

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：

 1272142606@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 speciallr@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：

陕西省西安市灞桥区辰宇世纪城

研究负责人通讯地址：

陕西省西安市灞桥区新寺路569号第四军医大学唐都医院

Applicant address：

Chenyu Century City, Baqiao District, Xi 'an City, Shaanxi Province

Study leader's address：

Tangdu Hospital, Fourth Military Medical University, No. 569 Xinsi Road, Baqiao District, Xi 'an City, Shaanxi 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：

空军军医大学第二附属医院康复科

Applicant's institution：

Department of Rehabilitation, Second Affiliated Hospital of Air Force Military Medical University

研究负责人所在单位：

空军军医大学第二附属医院康复科

Affiliation of the Leader：

Department of Rehabilitation, Second Affiliated Hospital of Air Force Military Medical University

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：

 第202307-16号

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：

第四军医大学唐都医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tangdu Hospital, Fourth Military Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-05 00:00:00

伦理委员会联系人：

李诗草

Contact Name of the ethic committee：

Li Shicao

伦理委员会联系地址：

陕西省西安市灞桥区新寺路569号第四军医大学唐都医院药剂科新办公楼304室

Contact Address of the ethic committee：

Room 304, New Office Building, Department of Pharmacy, Tangdu Hospital, Fourth Military Medical University, No.569 Xinsi Road, Baqiao District, Xi 'an City, Shaanxi Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 84717761

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 tangduec@126.com

研究实施负责（组长）单位：

空军军医大学第二附属医院康复科

Primary sponsor：

Department of Rehabilitation, Second Affiliated Hospital of Air Force Military Medical University

研究实施负责（组长）单位地址：

陕西省西安市灞桥区新寺路569号第四军医大学唐都医院

Primary sponsor's address：

Tangdu Hospital, Fourth Military Medical University, No. 569 Xinsi Road, Baqiao District, Xi 'an City, Shaanxi 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)：

西安市

市(区县)：

灞桥区

Country：

China

Province：

Xi 'an City

City：

Baqiao District

单位(医院)：

空军军医大学第二附属医院康复科

具体地址：

陕西省西安市灞桥区新寺路569号第四军医大学唐都医院

Institution
hospital：

Department of Rehabilitation, Second Affiliated Hospital of Air Force Military Medical University

Address：

Tangdu Hospital, Fourth Military Medical University, No. 569 Xinsi Road, Baqiao District, Xi 'an City, Shaanxi Province, China

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

研究疾病：

卒中后失语  

Target disease：

post-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：

 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：

观察不同靶点重复经颅磁刺激对脑卒中患者失语症恢复的影响，以期为临床上治疗此类患者提供更有效的治疗方案。  

Objectives of Study：

To observe the effect of different target repetitive transcranial magnetic stimulation on the recovery of aphasia in stroke patients, in order to provide a more effective treatment plan for clinical treatment of such patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准：(1)符合脑卒中诊断标准，且经 CT 或 MRI 确诊为脑卒中首次发病，病灶局限于左侧大脑半球；(2)经西方失语症检查 （WAB）诊断为非流畅性失语；(3)病程 1 周～6 个月，男女不限， 年龄 30～80 岁； (4)入组时意识清醒，生命体征平稳，能够进行并完成基础治疗；(5) 均为右利手；(6)发病前言语功能正常，母语为汉语； (7)有主动康复意愿并可以配合治疗指令； (8)患者和 （或）授权患者家属了解并签署知情同意书。

Inclusion criteria

Inclusion criteria : ( 1 ) According to the diagnostic criteria of stroke, the first onset of stroke was confirmed by CT or MRI, and the lesion was limited to the left cerebral hemisphere ; ( 2 ) Non-fluent aphasia was diagnosed by Western Aphasia Examination ( WAB ). ( 3 ) The course of disease was 1 week to 6 months, male and female, aged 30-80 years old ; ( 4 ) Conscious when entering the group, stable vital signs, able to carry out and complete basic treatment ; ( 5 ) All were right-handed ; ( 6 ) Before the onset of speech function is normal, mother tongue is Chinese ; ( 7 ) Willingness to actively recover and can cooperate with treatment instructions ; ( 8 ) Patients and / or authorized patients ' families to understand and sign the informed consent.

排除标准：

排除标准： (1)存在严重认知功能障碍或精神疾病，不能配合 治疗和评估者； (2)伴有严重的构音障碍；（3）颅内有金属异物 者；（4）有癫痫病史或癫痫家族史者；（5）有心脏起搏器、支架及耳蜗植入物者；（6）脑出血或蛛网膜下腔出血未吸收者。

Exclusion criteria：

Exclusion criteria : ( 1 ) patients with severe cognitive impairment or mental illness who cannot cooperate with treatment and evaluation ; ( 2 ) with severe dysarthria ; ( 3 ) Patients with intracranial metal foreign bodies ; ( 4 ) Patients with a history of epilepsy or family history of epilepsy ; ( 5 ) Patients with cardiac pacemakers, stents and cochlear implants ; ( 6 ) Cerebral hemorrhage or subarachnoid hemorrhage not absorbed.

研究实施时间：

Study execute time：

从 From 2023-04-01 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-07-17 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 15

Group：

Group A

Sample size：

干预措施：

先刺激左侧 DLPFC 区（刺激线圈平面与刺激靶点相切，治 疗强度采用健侧肢体运动诱发电位阈值的 90% ，刺激频率为 10Hz，刺激 0.5s，间歇 5s，刺激 109 次，总刺激时间 10 分钟， 总刺激脉冲数 545 个），然后刺激右侧 Broca 区（刺激线圈平面 与刺激靶点相切，治疗强度采用健侧肢体运动诱发电位阈值的 90%，刺激频率为 1Hz，刺激 10s，间歇 2s，刺激 50 次，总刺激时间 10 分钟，总刺激脉冲数 500 个）。

干预措施代码：

Intervention：

The left DLPFC area was stimulated first (the stimulation coil plane was tangential to the stimulation target, the treatment intensity was 90% of the healthy limb motor evoked potential threshold, the stimulation frequency was 10Hz, the stimulation frequency was 10Hz, the stimulation was 0.5s, the intermittent interval was 5s, the stimulation was done 109 times, the total stimulation time was 10 minutes, and the total stimulation pulses counted was 545), and the right Broca's area was stimulated first (the stimulation coil plane was tangential to the stimulation target, the intensity was 90% of the healthy limb motor evoked potential threshold, the stimulation frequency was 1Hz, the stimulation was 10s, the interval was 2s, the total stimulation time was 10 minutes, and the total stimulation pulse count was 500). Then the right Broca's area was stimulated (the stimulation coil plane was tangent to the stimulation target point, the treatment intensity was 90% of the threshold of the motor evoked potential of the healthy limb, the stimulation frequency was 1Hz, the stimulation was 10s, the intermittent interval was 2s, the stimulation was performed 50 times, the total stimulation time was 10 minutes, and the total stimulation pulse count was 500).

Intervention code：

组别：

B组

样本量：

 15

Group：

Group B

Sample size：

干预措施：

刺激左侧 DLPFC 区（刺激参数同左侧 DLPFC 区真刺激-右 侧 Broca 区真刺激组），然后刺激右侧 Broca 区(刺激参数同左侧 DLPFC 区真刺激-右侧 Broca 区真刺激组，刺激线圈与刺激靶点切面垂直，患者能听到刺激声音但无实际刺激作用）。

干预措施代码：

Intervention：

The left DLPFC area was stimulated first (the stimulation parameters were the same as those of the left DLPFC area true stimulation-right Broca area true stimulation group), and then the right Broca area was stimulated (the stimulation parameters were the same as those of the left DLPFC area true stimulation-right Broca area true stimulation group, and the stimulation coil was perpendicular to the cut surface of the stimulation target, so that the patient could hear stimulation sounds but had no actual stimulation effect).

Intervention code：

组别：

C组

样本量：

 15

Group：

Group C

Sample size：

干预措施：

先刺激左侧 DLPFC 区（刺激参数同左侧 DLPFC 区真刺激-右 侧 Broca 区真刺激组，刺激线圈与刺激靶点切面垂直，患者能听 到刺激声音但无实际刺激作用），然后刺激右侧 Broca 区（刺激参数同左侧 DLPFC 区真刺激-右侧 Broca 区真刺激组）。

干预措施代码：

Intervention：

The left DLPFC area was stimulated first (the stimulation parameters were the same as those of the left DLPFC area true stimulation-right Broca area true stimulation group, the stimulation coil was perpendicular to the cut surface of the stimulation target, and the patient could hear the stimulation sound but had no actual stimulation effect), and then the right Broca area was stimulated (the stimulation parameters were the same as those of the left DLPFC area true stimulation-right Broca area true stimulation group).

Intervention code：

组别：

D组

样本量：

 15

Group：

Group D

Sample size：

干预措施：

先刺激左侧 DLPFC 区，然后刺激右侧 Broca 区，均为假刺激。

干预措施代码：

Intervention：

Stimulating the left DLPFC area first, and then stimulating the right Broca area, are both false stimulation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 西安市 

市(区县)：

 灞桥区 

Country：

China

Province：

Xi 'an City

City：

Baqiao District

单位(医院)：

 空军军医大学第二附属医院康复科 

单位级别：

 三甲 

Institution
hospital：

Department of Rehabilitation, Second Affiliated Hospital of Air Force Military Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

西方失语成套测验（WAB)

指标类型：

主要指标

Outcome：

Western Aphasia Battery ( WAB )

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

波士顿失语诊断测验（BDAE)

指标类型：

次要指标

Outcome：

Boston Aphasia Diagnostic Test(BDAE)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

日常生活活动能力量表(ADL)

指标类型：

次要指标

Outcome：

activity of daily living scale(ADL)

Type：

Secondary 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(MoCA)

指标类型：

次要指标

Outcome：

Montreal Cognitive Assessment ( MoCA )

Type：

Secondary 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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 30 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）：

由治疗师用随机数表法产生随机序列

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

Random sequences were generated by the therapist 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：

单盲，受试者不知道自己接受哪种治疗方案。

Blinding：

Single-blind method

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

是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）：

公开日期;2025-06-30 方式：国家生物信息中心(https://ngdc.cncb.ac.cn/gsub/)

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

Public date ; 2025-06-30 Way : China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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：

病例记录表

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

Medical record sheet

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：

  2025-08-19 17:31:43