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Study on the efficacy and multimodal imaging mechanism of electroacupuncture in the treatment of acute ischemic stroke based on the theory of stasis-toxin interconnection

注册号：

Registration number：

ITMCTR2024000876

最近更新日期：

Date of Last Refreshed on：

2024-12-27

注册时间：

Date of Registration：

2024-12-27

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于瘀毒互结理论探究电针治疗急性缺血性脑卒中的疗效和多模态影像学机制研究

Public title：

Study on the efficacy and multimodal imaging mechanism of electroacupuncture in the treatment of acute ischemic stroke based on the theory of stasis-toxin interconnection

注册题目简写：

电针治疗急性脑梗死的疗效与机制研究

English Acronym：

Study on the efficacy and mechanism of electroacupuncture in the treatment of acute cerebral infarction

研究课题的正式科学名称：

基于瘀毒互结理论探究电针治疗急性缺血性脑卒中的疗 效和多模态影像学机制研究

Scientific title：

Study on the efficacy and multimodal imaging mechanism of electroacupuncture in the treatment of acute ischemic stroke based on the theory of stasis-toxin interconnection

研究课题的正式科学名称简写：

Scientific title acronym：

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：

张琦

研究负责人：

张允岭

Applicant：

Qi Zhang

Study leader：

Yunling Zhang

申请注册联系人电话：

Applicant telephone：

13718898837

研究负责人电话：

Study leader's telephone：

13910764257

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：

771933109@qq.com

研究负责人电子邮件：

Study leader's E-mail：

xyyyzq95@gmail.com

申请单位网址(自愿提供)：

Study leader's 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：

北京市海淀区操场路1号中国中医科学院西苑医院

研究负责人通讯地址：

北京市海淀区操场路1号中国中医科学院西苑医院

Applicant address：

Xiyuan Hospital China Academy of Traditional Chinese Medicine No. 1 Caochang Road Haidian District Beijing China

Study leader's address：

Xiyuan Hospital China Academy of Traditional Chinese Medicine No. 1 Caochang Road Haidian District Beijing 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：

中国中医科学院西苑医院

Applicant's institution：

Xiyuan Hospital China Academy of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2024XLA185-2

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee Xiyuan Hospital China Academy of Traditional Chinese Medicine China

伦理委员会批准日期：

Date of approved by ethic committee：

2024/11/1 0:00:00

伦理委员会联系人：

徐浩

Contact Name of the ethic committee：

Hao Xu

伦理委员会联系地址：

北京市海淀区操场路1号

Contact Address of the ethic committee：

No.1 Qiangchang Road Haidian District Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-62835646

伦理委员会联系人邮箱：

Contact email of the ethic committee：

xyyyzq95@gmail.com

研究实施负责（组长）单位：

中国中医科学院西苑医院

Primary sponsor：

Xiyuan Hospital China Academy of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市海淀区操场路1号

Primary sponsor's address：

No.1 Qiangchang Road Haidian 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)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国中医科学院西苑医院

具体地址：

北京市海淀区操场路1号

Institution
hospital：

Xiyuan Hospital China Academy of Traditional Chinese Medicin

Address：

No.1 Qiangchang Road Haidian District Beijing

经费或物资来源：

中国中医科学院中医药防治脑病传承创新团队（CI2021B006）

Source(s) of funding：

China Academy of Traditional Chinese Medicine TCM Prevention and Treatment of Cerebral Diseases Inheritance Innovation Team (CI2021B006)

研究疾病：

缺血性脑卒中

研究疾病代码：

Target disease：

ischemic stroke

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

初步评价电针治疗急性缺血性脑卒中“瘀毒互结证”的临床有效性及安全性，探索其神经影像学效应机制。

Objectives of Study：

To preliminarily evaluate the clinical efficacy and safety of electroacupuncture in the treatment of acute ischemic stroke with "stasis and toxicity syndrome" and to explore the mechanism of its neuroimaging effect.

药物成份或治疗方案详述：

该实验分为电针组和对照组，取穴均为：双侧曲池、合谷、内庭、太冲、血海、丰隆、足三里以及百会、神庭、四神聪。干预频率均为每周治疗5次，共治疗2周。 电针组针下得气后,采用提插泄法（先深后浅,轻插重提,以上提用力为主）、捻转泄法（拇指向后用力重,向前用力轻,快速地捻转针身）以及徐疾泄法（进针时疾速刺入,徐徐出针）加强针刺效应。电针仪两级分别连接患侧曲池穴、内庭穴、血海穴以及该穴位循经下一寸，电针参数为：连续波型，电流频率2Hz，电流强度小于1mA，以患者耐受为度，持续30分钟。 对照组为假针治疗，采用安慰对照针实现患者侧盲法（不刺入穴位，但产生针刺感觉），特制电针仪（连通电源后，指示灯正常亮起，但无电流输出）连接患侧曲池穴、内庭穴、血海穴以及该穴位循经下一寸，持续30分钟。

Description for medicine or protocol of treatment in detail：

The experiment was divided into an electroacupuncture group and a control group and the acupoints were: bilateral Quchi Hegu Neitian Taichong Blood Sea Fenglong and Foot Sanli as well as Baihui Shenting and Shishencong. The frequency of intervention was 5 times per week for 2 weeks. After the electroacupuncture group obtained qi under the needle the method of lifting and inserting and draining was used (first deep and then shallow light insertion and heavy lifting with the upper lifting force as the main force) the method of twisting and draining was used (the thumb was applied backward with a heavy force and forward with a light force and the body of the needle was twisted quickly) and the method of Xuqi draining was used (the needle was stabbed in at a rapid pace and then discharged out at a slow pace) to strengthen the effect of needling. The two levels of electroacupuncture instrument were connected to the affected side Quchi point Neiting point Blood Sea point and one inch below the meridian of the point respectively the parameters of electroacupuncture were: continuous wave type current frequency of 2Hz current intensity of less than 1mA to the extent that the patient tolerated it for 30 minutes. The control group was sham acupuncture treatment using a comfort control needle to realize the patient's side of the blind method (not piercing the acupoints but produce the sensation of needling) the special electroacupuncture instrument (after connecting to the power supply the indicator light is normally on but no current output) connected to the affected side of the Quchi point the Neiting point the Sea of Blood point as well as the point of the meridian of the next inch lasted for 30 minutes.

纳入标准：

（1）符合《中国急性缺血性卒中诊治指南2023》中急性缺血性脑卒中诊断标准以及瘀毒互结证证候诊断标准 （2）首次发病； （3）病程：≤7天； （4）NIHSS评分：≤15分。 （5）年龄在18～80岁之间； （6）GCS评分≥9分； （7）自愿受试并签署知情同意书。 （8）右利手患者； （9）梗死灶责任血管为左侧大脑中动脉供血区。

Inclusion criteria

(1) Comply with the diagnostic criteria of acute ischemic stroke and the diagnostic criteria of stasis-toxicity syndrome in the China Acute Ischemic Stroke Diagnostic Guidelines 2023 (2) First onset of disease; (3) Duration of the disease: ≤7 days; (4) NIHSS score: ≤15 points. (5) Age between 18 and 80 years old; (6) GCS score ≥9; (7) Voluntary and signed informed consent. (8) Right-handed patients; (9) The vessel responsible for the infarct focus was the left middle cerebral artery blood-supplying area.

排除标准：

（1）符合溶栓/取栓治疗条件并准备接受溶栓/取栓治疗的患者或已经接受溶栓/取栓治疗的患者； （2）存在晕针、晕血等不能接受电针治疗的患者； （3）皮肤存在严重破溃或皮肤疾病不能接受针灸治疗的患者； （4）合并严重的循环、呼吸、泌尿、消化系统疾病以及癌症，在MRI扫描中发现其他器质性病变（如脑肿瘤等）者； （5）有精神病史、智力缺陷、行动不便、失语、认知障碍或其他将限制参与本研究知情同意有效性，或疗效测评者； （6）2周内接受过活血解毒类中药治疗、近3个月内参加过其他临床试验者或不能依从研究方案者； （7）妊娠、哺乳期妇女或近期有备孕需要的妇女； （8）经过临床评估，认为不适宜参加临床试验者。 （9）存在幽闭恐惧症或体内存在金属（如心脏支架、介入、假牙等）等其他磁共振检查禁忌症，或不能配合核磁检查者；

Exclusion criteria：

(1) Patients who are eligible for thrombolysis/thrombolysis and are ready to receive thrombolysis/thrombolysis or have already received thrombolysis/thrombolysis; (2) Patients who cannot receive electroacupuncture treatment due to the presence of needle-sickness blood-sickness etc.; (3) Patients with severe skin ulcers or skin diseases who cannot receive acupuncture treatment; (4) Patients with severe combined circulatory respiratory urinary digestive diseases and cancer and those with other organic lesions (e.g. brain tumors) detected in MRI scans; (5) Patients with a history of mental retardation mobility impairment cognitive impairment or other conditions that would limit the validity of informed consent for participation in this study or the evaluation of treatment; and (5) Patients with a history of mental illness intellectual disability mobility problems aphasia cognitive impairment or other conditions that would limit the validity of their informed consent to participate in the study or the efficacy of the study; (6) Patients who have been treated with blood-activating and detoxifying herbal medicines within 2 weeks or those who have participated in other clinical trials in the past 3 months or those who are unable to comply with the study protocol; (7) Pregnant or breastfeeding women or women who have been preparing for pregnancy in the near future (7) Pregnant or lactating women or women who have recently prepared for pregnancy; (8) Those who have been clinically assessed as unsuitable to participate in the clinical trial. (9) Those who have claustrophobia or other contraindications to MRI such as the presence of metal in the body (e.g. cardiac stents interventions dentures etc.) or those who are unable to cooperate with the MRI;

研究实施时间：

Study execute time：

从From 2024-11-01

至To      2026-06-01

征募观察对象时间：

Recruiting time：

从From 2024-12-01

至To      2025-12-01

干预措施：

Interventions：

组别：

电针组

样本量：

42

Group：

electroacupuncture group

Sample size：

干预措施：

电针治疗

干预措施代码：

Intervention：

electroacupuncture (EA)

Intervention code：

组别：

对照组

样本量：

42

Group：

control group

Sample size：

干预措施：

安慰对照治疗

干预措施代码：

Intervention：

Placebo-controlled treatment

Intervention code：

样本总量 Total sample size ： 84

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)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国中医科学院西苑医院

单位级别：

三级甲等医院

Institution/hospital：

Xiyuan Hospital China Academy of Traditional Chinese Medicine

Level of the institution：

3A hospital

测量指标：

Outcomes：

指标中文名：

肢体运动功能Fugl-Meyer量表

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment scale (FMA)

Type：

Primary indicator

测量时间点：

入组第1天、第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行临床量表评价

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

Clinical scale evaluations by assessors trained and unaware of subgroups

指标中文名：

多模态磁共振成像

指标类型：

附加指标

Outcome：

multimodal magnetic resonance imaging (MRI)

Type：

Additional indicator

测量时间点：

入组第1天、第14天

测量方法：

采集磁敏感加权成像（SWI）、功能磁共振成像（fMRI）、T1结构像作为原始核磁资料进行后续分析

Measure time point of outcome：

Day 1 Day 14 after enrolment

Measure method：

Acquisition of magnetic susceptibility weighted imaging (SWI) functional magnetic resonance imaging (fMRI) and T1 structural images as raw MRI data for subsequent analysis

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

adverse event

Type：

Adverse events

测量时间点：

入组第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行不良事件记录

Measure time point of outcome：

Day 7 Day 14 after enrolment

Measure method：

Adverse event recording by assessors who are trained and unaware of subgroups

指标中文名：

中医症状观察表

指标类型：

次要指标

Outcome：

Chinese Medicine Symptom Observation Chart

Type：

Secondary indicator

测量时间点：

入组第1天、第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行中医症状观察量表评价

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

TCM Symptom Observation Scale evaluation by trained evaluators who are unaware of subgroups

指标中文名：

功能独立性改良Rankin量表

指标类型：

次要指标

Outcome：

Modified Rankin Scale（mRS）

Type：

Secondary indicator

测量时间点：

入组第1天、第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行临床量表评价

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

Clinical scale evaluations by assessors trained and unaware of subgroups

指标中文名：

美国国立卫生研究院卒中量表

指标类型：

主要指标

Outcome：

National Institute of Health Stroke Scale（ NIHSS）

Type：

Primary indicator

测量时间点：

入组第1天、第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行临床量表评价

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

Clinical scale evaluations by assessors trained and unaware of subgroups

指标中文名：

终点事件

指标类型：

附加指标

Outcome：

terminal event

Type：

Additional indicator

测量时间点：

入组第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行终点事件记录，如好转、痊愈、恶化、死亡等

Measure time point of outcome：

Day 7 Day 14 after enrolment

Measure method：

Endpoint event recording by assessors trained and unaware of subgroups e.g. improvement recovery deterioration death

指标中文名：

日常生活能力量表

指标类型：

次要指标

Outcome：

Activity of Daily Living（ADL）

Type：

Secondary indicator

测量时间点：

入组第1天、第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行临床量表评价

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

Clinical scale evaluations by assessors trained and unaware of subgroups

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

Modified Barthel Index（MBI）

Type：

Secondary indicator

测量时间点：

入组第1天、第7天、第14天

测量方法：

由受过培训并且不知道分组情况的评估人员进行临床量表评价

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

Clinical scale evaluations by assessors trained and unaware of subgroups

指标中文名：

生命体征

指标类型：

副作用指标

Outcome：

vital signs

Type：

Adverse events

测量时间点：

入组第1天、第7天、第14天

测量方法：

如体温、血压、呼吸、心率等

Measure time point of outcome：

Day 1 Day 7 Day 14 after enrolment

Measure method：

Such as temperature blood pressure respiration heart rate etc.

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

使用后销毁

说明

用于神经炎性因子等科研检测

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究由中国中医科学院西苑医院GCP中心指定统计专家负责随机化方案。以 SAS 9.4统计软件产生随机号以及随机号所对应治疗方案。

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

The study was conducted by a designated statistician from the GCP Center of Xiyuan Hospital China Academy of Traditional Chinese Medicine who was responsible for the randomization protocol. SAS 9.4 statistical software was used to generate the random number and the treatment protocol corresponding to the random number.

盲法：

本研究采用盲法（受试者、评价者、数据分析者），由中国中医科学院西苑医院 GCP 中心指定统计专家负责，不涉及编盲程序。

Blinding：

The study was blinded (subjects evaluators and data analysts) and was conducted by a designated statistical expert at the GCP Center of Xiyuan Hospital China Academy of Traditional Chinese Medicine and did not involve coded blinding procedures.

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）：

公开数据日期为2026年12月，通过邮件询问通讯作者

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

No sharing of raw data

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：

设计本研究专用的病历报告表，并由专人负责记录保存，定期更新进电子表格中进行统一数据管理，另外由专门监督小组负责检查数据质量和完整性，并在试验完成后出具监督报告。

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

A medical record report form dedicated to this study was designed and maintained by a person responsible for record keeping and regularly updated into a spreadsheet for uniform data management in addition to a specialized supervisory team responsible for checking data quality and completeness and issuing a supervisory report upon completion of the trial.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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