ChiCTR2400083951 版本V1.0 版本创建时间2024/05/08 10:30:47 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：

ChiCTR2400083951 

最近更新日期：

Date of Last Refreshed on：

2024-05-08 10:30:41 

注册时间：

Date of Registration：

2024-05-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

巨刺联合重复经颅磁刺激对脑卒中患者恢复期运动功能的疗效研究

Public title：

The therapeutic effect of contralateral acupuncture combined with repeated transcranial magnetic stimulation on motor function in stroke patients during the recovery period

注册题目简写：

English Acronym：

研究课题的正式科学名称：

巨刺联合重复经颅磁刺激对脑卒中患者恢复期运动功能的疗效研究

Scientific title：

The therapeutic effect of contralateral acupuncture combined with repeated transcranial magnetic stimulation on motor function in stroke patients during the recovery period

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：

宋振旺 

研究负责人：

王杰宁 

Applicant：

Song Zhenwang 

Study leader：

Wang Jiening 

申请注册联系人电话：

Applicant telephone：

+86 178 3997 4348

研究负责人电话：

Study leader's telephone：

+86 139 0163 4270

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：

shxzhysong321@163.com

研究负责人电子邮件：

Study leader's E-mail：

drwjn0606@sina.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：

中国上海市浦东新区高桥镇高荷路380号8601

研究负责人通讯地址：

中国上海市浦东新区高桥镇大同路358号

Applicant address：

8601, No. 380 Gaohe Road, Gaoqiao Town, Pudong New Area, Shanghai, China

Study leader's address：

358 Datong Road, Gaoqiao Town, 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

Applicant's institution：

Shanghai University of Traditional Chinese Medicine

研究负责人所在单位：

上海中医药大学附属第七人民医院

Affiliation of the Leader：

Shanghai University of Traditional Chinese Medicine Affiliated Seventh People's Hospital

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：

2024-7th-HIRB-025

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：

上海市第七人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Seventh People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-04-23 00:00:00

伦理委员会联系人：

张春燕

Contact Name of the ethic committee：

Zhang Chunyan

伦理委员会联系地址：

上海市浦东新区高桥镇大同路358号1号楼辅楼203室

Contact Address of the ethic committee：

Room 203, Auxiliary Building, Building 1, No. 358 Datong Road, Gaoqiao Town, Pudong New Area, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 5867 0561

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：

上海市第七人民医院

Primary sponsor：

Shanghai Seventh People's Hospital

研究实施负责（组长）单位地址：

上海市浦东新区高桥镇大同路358号

Primary sponsor's address：

No. 358 Datong Road, Gaoqiao Town, Pudong New Area, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

上海市

市(区县)：

上海市

Country：

People's Republic of China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海市第七人民医院

具体地址：

上海市浦东新区高桥镇大同路358号

Institution
hospital：

Shanghai Seventh People's Hospital

Address：

No. 358 Datong Road, Gaoqiao Town, Pudong New Area, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

raise independently

Target disease：

cerebral apoplexy

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

本研究采用随机对照试验1：1优效性实验设计，对照组常规患侧针刺基础上联合rTMS，试验组将在对照组基础上加健侧针刺。根据随机对照原则，在对照组健侧采用非侵入式假针刺。评估巨刺联合rTMS对脑卒中偏瘫肢体功能障碍的疗效，观察患者肢体功能、日常生活能力等方面的改善情况。探讨巨刺联合rTMS的作用机制，研究其对脑卒中偏瘫患者神经功能的影响，从神经传导、精准神经环路调控等方面的变化探究针刺和重复经颅磁刺激各自发挥作用的机制以及联合治疗疗效的机理。  

Objectives of Study：

This study adopted a randomized controlled trial with a 1:1 superiority experimental design. The control group received conventional acupuncture on the affected side in combination with rTMS, while the experimental group received acupuncture on the healthy side in addition to the control group. Evaluate the therapeutic effect of the combination of giant needling and rTMS on stroke hemiplegic limb dysfunction, and observe the improvement of limb function, daily living ability, and other aspects in patients. Explore the mechanism of action of the combination of giant needling and rTMS, investigate its impact on the neurological function of stroke hemiplegic patients, and explore the mechanisms of acupuncture and repetitive transcranial magnetic stimulation in terms of changes in nerve conduction, precise neural circuit regulation, and the therapeutic effect of the combination therapy.

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)脑卒中发病后２周～6个月； (2)首次发病，单侧病灶，病变部位为单侧皮质下脑卒中（基底核、丘脑、内囊、放射冠）者，出现上肢肢体一侧运动功能障碍； (3)自愿参加本临床试验，本人或家属签署知情同意书；

Inclusion criteria

(1) 2 weeks to 6 months after the onset of stroke; (2) First onset, unilateral lesion, located in a unilateral subcortical stroke (basal nucleus, thalamus, internal capsule, corona radiata), with motor dysfunction on one side of the upper limb; (3) Voluntarily participate in this clinical trial, and either the individual or their family member signs an informed consent form;

排除标准：

(1)脑外伤、脑肿瘤及颅脑术后等非脑血管病变原因所致的偏瘫者； (2)有严重的心、肺、肝、肾等器官功能衰竭者； (3)既往有过脑卒中发作史和/或遗留有肢体功能障碍者； (4)依从性差，不按医嘱进行治疗者； (5)存在偏侧忽略或偏盲者； (6)针刺不耐受的患者；排除孕妇； (7)存在出血倾向者；伴有脑肿瘤、动脉畸形、静脉畸形者；患有严重心脏瓣膜病、心源性栓塞者等； (8)体内含有心脏起搏器、支架、人工耳蜗等金属器件等不适宜进行经颅磁刺激的患者； (9)存在与放电线圈紧密接触的金属硬件(如耳蜗植入物、内部脉冲发生器或药物泵)。 (10)头颅内有由银和金制成的电极,金属脑植入物。 (11)体内的电子元件(如位于颈部或躯干的IPG)与TMS线圈的距离小于10cm的患者(如:心脏起搏器、迷走神经刺激系统和脊髓刺激器)禁用。 (12)深部脑刺激植入脉冲发生器与经颅磁刺激线圈距离小于10cm的患者禁用； (13)有癫痫发作史、频繁的头疼耳鸣及药物滥用，近两周使用麻醉学镇痛药物。

Exclusion criteria：

(1) Hemiplegia caused by non cerebrovascular diseases such as traumatic brain injury, brain tumor, and postoperative brain surgery; (2) Individuals with severe organ failure such as heart, lung, liver, and kidney; (3) Individuals with a history of stroke and/or residual limb dysfunction; (4) Poor compliance and failure to follow medical advice for treatment; (5) Individuals with unilateral neglect or blindness; (6) Patients with acupuncture intolerance; Excluding pregnant women; (7) Individuals with a tendency towards bleeding; Patients with brain tumors, arterial malformations, and venous malformations; Individuals with severe heart valve disease, cardioembolic conditions, etc; (8) Patients whose bodies contain metal devices such as pacemakers, stents, and cochlear implants that are not suitable for transcranial magnetic stimulation; (9) There are metal hardware in close contact with the discharge coil, such as cochlear implants, internal pulse generators, or drug pumps. (10) There are electrodes made of silver and gold in the skull, as well as metal brain implants. (11) Patients with electronic components (such as IPG located in the neck or torso) within a distance of less than 10cm from the TMS coil (such as pacemakers, vagus nerve stimulation systems, and spinal cord stimulators) are prohibited from using electronic components within the body. (12) Patients with a distance of less than 10cm between the implanted pulse generator for deep brain stimulation and the transcranial magnetic stimulation coil are prohibited; (13) Having a history of epileptic seizures, frequent headaches, tinnitus, and drug abuse, using anesthetic analgesics in the past two weeks.

研究实施时间：

Study execute time：

从 From 2024-05-01 00:00:00至 To 2025-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-13 00:00:00 至 To 2025-05-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

44

Group：

control group

Sample size：

干预措施：

对照组在常规康复治疗基础上给予患侧针刺治疗联合rTMS治疗，治疗4周。（1）针刺方案：肩井、曲池、手三里、合谷、血海、环跳、阳陵泉、阴陵泉、足三里、绝谷（悬钟）、昆仑，一共11个穴位。行重插轻提之补法，以3次重插轻提补法为1组，每穴3组，留针30min。每天一次，一周5次，四周为一疗程。针刺均由同一位具备五年以上治疗脑卒中肢体运动障碍经验的针灸医师进行操作。（2）重复经颅磁刺激治疗：武汉依瑞德经颅磁刺激治疗仪，在被试者健侧大脑皮层M1区，八字线圈1Hz，100%-120%静息阈值，每发放100 个磁脉冲暂停10s，重复10次，总计1000个脉冲，时间为18min，亚急性期每天1次，每周5次的治疗方案，10～20次为1个疗程，根据患者病情和疗效可连续治疗2～3个疗程。连续治疗 4 周。

干预措施代码：

Intervention：

The control group received acupuncture treatment on the affected side combined with rTMS treatment on the basis of routine rehabilitation treatment for 4 weeks. (1) Acupuncture plan: There are a total of 11 acupoints, including Shaanjing, Quchi, Shousanli, Hegu, Xuehai, Huantiao, Yangling Spring, Yinling Spring, Zusanli, Juegu (Xuanzhong), and Kunlun. The method of supplementing with heavy insertion and light lifting is divided into one group of three times, with three groups per acupoint and 30 minutes of needle retention. Once a day, five times a week, for a course of treatment of four weeks. Acupuncture was performed by the same acupuncture and moxibustion with more than five years' experience in treating stroke limb dyskinesia. (2) Repetitive transcranial magnetic stimulation therapy: Wuhan Yiruide transcranial magnetic stimulation therapy device is used in the healthy side of the M1 area of the cerebral cortex of the subject. The octagonal coil is 1Hz, with a resting threshold of 100% -120%. Each 100 magnetic pulses are paused for 10 seconds, repeated 10 times, for a total of 1000 pulses for 18 minutes. In the subacute phase, the treatment plan is once a day, five times a week, and 10-20 times is a course of treatment. Depending on the patient's condition and efficacy, the treatment can be continued for 2-3 courses. Continuous treatment for 4 weeks.

Intervention code：

组别：

试验组

样本量：

44

Group：

Experimental group

Sample size：

干预措施：

对照组在常规康复治疗基础上给予分期巨刺联合rTMS治疗，即先针刺健侧2周，再针刺患侧2周，一共治疗4周。（1）针刺方案：肩井、曲池、手三里、合谷、血海、环跳、阳陵泉、阴陵泉、足三里、绝谷（悬钟）、昆仑，一共11个穴位。行重插轻提之补法，以3次重插轻提补法为1组，每穴3组，留针30min。每天一次，一周5次，四周为一疗程。针刺均由同一位具备五年以上治疗脑卒中肢体运动障碍经验的针灸医师进行操作。（2）重复经颅磁刺激治疗：武汉依瑞德经颅磁刺激治疗仪，在被试者健侧大脑皮层M1区，八字线圈1Hz，100%-120%静息阈值，每发放100 个磁脉冲暂停10s，重复10次，总计1000个脉冲，时间为18min，亚急性期每天1次，每周5次的治疗方案，10～20次为1个疗程，根据患者病情和疗效可连续治疗2～3个疗程。连续治疗 4 周。

干预措施代码：

Intervention：

The control group was treated with staged giant needling combined with rTMS on the basis of routine rehabilitation treatment, which first needled the healthy side for 2 weeks, and then needled the affected side for 2 weeks, for a total of 4 weeks of treatment. (1) Acupuncture plan: There are a total of 11 acupoints, including Shaanjing, Quchi, Shousanli, Hegu, Xuehai, Huantiao, Yangling Spring, Yinling Spring, Zusanli, Juegu (Xuanzhong), and Kunlun. The method of supplementing with heavy insertion and light lifting is divided into one group of three times, with three groups per acupoint and 30 minutes of needle retention. Once a day, five times a week, for a course of treatment of four weeks. Acupuncture was performed by the same acupuncture and moxibustion with more than five years' experience in treating stroke limb dyskinesia. (2) Repetitive transcranial magnetic stimulation therapy: Wuhan Yiruide transcranial magnetic stimulation therapy device is used in the healthy side of the M1 area of the cerebral cortex of the subject. The octagonal coil is 1Hz, with a resting threshold of 100% -120%. Each 100 magnetic pulses are paused for 10 seconds, repeated 10 times, for a total of 1000 pulses for 18 minutes. In the subacute phase, the treatment plan is once a day, five times a week, and 10-20 times is a course of treatment. Depending on the patient's condition and efficacy, the treatment can be continued for 2-3 courses. Continuous treatment for 4 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中华人民共和国

省(直辖市)：

 上海市 

市(区县)：

 上海市 

Country：

People's Republic of China 

Province：

Shanghai  

City：

Shanghai  

单位(医院)：

上海市第七人民医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Seventh People's Hospital

Level of the institution：

Level III Grade A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer评定量表

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment-Upper Extremities

Type：

Primary indicator

测量时间点：

测量方法：

量表收集

Measure time point of outcome：

Measure method：

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

modified Barthel Index

Type：

Secondary indicator

测量时间点：

测量方法：

量表收集

Measure time point of outcome：

Measure method：

指标中文名：

Lovett肌力分级

指标类型：

次要指标

Outcome：

Lovett muscle strength grading

Type：

Secondary indicator

测量时间点：

测量方法：

量表收集

Measure time point of outcome：

Measure method：

指标中文名：

经颅磁刺激运动诱发电位(MEP)皮质潜伏期、波幅、中枢运动传导时间

指标类型：

次要指标

Outcome：

d potential (MEP) cortical latency, amplitude, and central motor conduction time

Type：

Secondary indicator

测量时间点：

测量方法：

经颅磁刺激仪多次测量，求平均值

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 85 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）：

简单随机数字序列法，由研究负责人使用SPSS27.0随机数字生成法产生随机序列，种子号20240403。

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

Simple random number sequence method, generated by the research leader using SPSS 27.0 random number generation method, seed number 20240403.

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，医师或治疗师在评估患者运动功能时不知道患者的具体分组

Blinding：

Single blind, physicians or therapists do not know the specific grouping of patients when evaluating their motor function

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

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）：

中国临床试验注册中心临床试验公共管理平台 ResMan

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

ResMan

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：

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-05-08 10:30:41