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Observation on the sensitizing effect and mechanism of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis based on "Facial Oral Hegu Shu"

注册号：

Registration number：

ITMCTR2024000296

最近更新日期：

Date of Last Refreshed on：

2024-08-24

注册时间：

Date of Registration：

2024-08-24

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于“面口合谷收”观察针刺合谷穴对经颅磁磁刺激治疗外周性面瘫的增敏作用及机制研究

Public title：

Observation on the sensitizing effect and mechanism of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis based on "Facial Oral Hegu Shu"

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“面口合谷收”观察针刺合谷穴对经颅磁磁刺激治疗外周性面瘫的增敏作用及机制研究

Scientific title：

Observation on the sensitizing effect and mechanism of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis based on "Facial Oral Hegu Shu"

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：

胥琛

研究负责人：

陈军

Applicant：

Xu Chen

Study leader：

Chen Jun

申请注册联系人电话：

Applicant telephone：

15129790108

研究负责人电话：

Study leader's telephone：

15991032768

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：

1172111760@qq.com

研究负责人电子邮件：

Study leader's E-mail：

584432697@qq.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：

陕西省咸阳市秦都区渭阳西路5号

研究负责人通讯地址：

陕西省咸阳市秦都区渭阳西路5号

Applicant address：

No. 5, Weiyang West Road, Qindu District, Xianyang City, Shaanxi Province

Study leader's address：

No. 5, Weiyang West Road, Qindu District, Xianyang City, Shaanxi Province

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：

陕西中医药大学

Applicant's institution：

Shaanxi University 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：

KJT-SQ2024002

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：

陕西中医药大学第二附属医院药物临床试验伦理委员会

Name of the ethic committee：

Drug Clinical Trial Ethics Committee of the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/8/15 0:00:00

伦理委员会联系人：

刘丹

Contact Name of the ethic committee：

Liu Dan

伦理委员会联系地址：

陕西省咸阳市西咸新区沣西新城龙台观路831号

Contact Address of the ethic committee：

No. 831, Longtaiguan Road, Fengxi New Town, Xixian New District, Xianyang City, Shaanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

13720452116

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kycxgzb@163.com

研究实施负责（组长）单位：

陕西中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

陕西省咸阳市西咸新区沣西新城龙台观路831号

Primary sponsor's address：

No. 831, Longtaiguan Road, Fengxi New Town, Xixian New District, Xianyang City, Shaanxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西

市(区县)：

咸阳

Country：

China

Province：

Shaanxi

City：

Xianyang

单位(医院)：

陕西中医药大学第二附属医院

具体地址：

陕西省咸阳市西咸新区沣西新城龙台观路831号

Institution
hospital：

The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Address：

No. 831, Longtaiguan Road, Fengxi New Town, Xixian New District, Xianyang City, Shaanxi Province

经费或物资来源：

课题经费

Source(s) of funding：

Project funding

研究疾病：

周围性面神经麻痹

研究疾病代码：

Target disease：

peripheral facial nerve palsy

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

1、明确针刺合谷穴对经颅磁刺激治疗外周性面瘫的增效作用。 2、通过经颅磁刺激诱发动作电位技术探索“面口合谷收”的机制。 3、依据针刺不同穴位对面部诱发动作电位的差异，分析不同穴位对于外周性面瘫治疗效果的差异性。 4、为临床治疗外周性面瘫提供新的治疗方案。

Objectives of Study：

1. To clarify the synergistic effect of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis. 2. Explore the mechanism of "face-oral retraction" through transcranial magnetic stimulation-induced action potential technology. 3. Based on the differences in facial evoked action potentials caused by acupuncture at different acupoints, analyze the differences in the therapeutic effects of different acupoints on peripheral facial paralysis. 4. Provide new treatment options for clinical treatment of peripheral facial paralysis.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

本实验总共分为健康受试者研究和周围性面神经麻痹患者研究两部分。 一、健康志愿者组志愿者纳入标准 （1） 年龄 18～35 岁,性别不限; （2） 右利手; （3） 既往身体健康，可以耐受针刺及经颅磁刺激； （4） 试验阶段无身体异常（如发热、咳嗽等）； （5） 自愿参与此次研究,充分理解并签署知情同意书。 病例需全部满足上述5条标准方可纳入。 二、外周性面瘫患者组病例纳入标准： （1） 符合外周性面瘫的中医诊断标准和西医诊断标准； （2） 患者对所用经颅磁、针灸均无治疗禁忌； （3） 首次确诊且为单侧患病； （4） 年龄 18～65 岁,性别不限; （5） 自愿参与此次研究,充分理解并签署知情同意书。 病例需全部满足上述5条标准方可纳入。

Inclusion criteria

This experiment is divided into two parts: a study on healthy subjects and a study on patients with peripheral facial nerve palsy. 1. Inclusion criteria for volunteers in the healthy volunteer group (1) Age 18 to 35 years old, no gender limit; (2) Right-handed; (3) Have good health in the past and can tolerate acupuncture and transcranial magnetic stimulation; (4) No physical abnormalities (such as fever, cough, etc.) during the trial period; (5) Voluntarily participate in this study, fully understand and sign the informed consent form. Cases must all meet the above five criteria to be included. 2. Inclusion criteria for patients with peripheral facial paralysis: (1) Meet the diagnostic standards of traditional Chinese medicine and Western medicine for peripheral facial paralysis; (2) The patient has no contraindications to the transcranial magnetism and acupuncture used; (3) Diagnosed for the first time and unilaterally affected; (4) Age 18 to 65 years old, no gender limit; (5) Voluntarily participate in this study, fully understand and sign the informed consent form. Cases must all meet the above five criteria to be included.

排除标准：

本实验总共分为健康受试者研究和周围性面神经麻痹患者研究两部分。 一、健康志愿者组志愿者排除标准 （1） 有颅脑外伤、手术史者; （2） 有帕金森病、痴呆等神经系统疾患者; （3） 患有高血压、糖尿病及重大心、肝、肾等脏器疾患者； （4） 体内有起搏器、支架等金属物者; （5） 恐惧或因其他原因不能进行针刺、TMS 或周围神经电刺激者; （6） 怀孕者。 （7） 合并有严重的脑血管、恶性肿瘤、血液及精神系统疾病的患者； （8） 同时参加了其他临床试验的临床试验者； 注：凡符合上述任何一条的患者，即应予以排除。 2、二、外周性面瘫患者组病例排除病例标准： （1） 有颅脑外伤、手术史者; （2） 有帕金森病、痴呆等神经系统疾患者; （3） 患有高血压、糖尿病及重大心、肝、肾等脏器疾患者； （4） 体内有起搏器、支架等金属物者; （5） 恐惧或因其他原因不能进行针刺、TMS 或周围神经电刺激者; （6） 孕期、围产期及哺乳期妇女； （7） 合并有严重的脑血管、恶性肿瘤、血液及精神系统疾病的患者； （8） 同时参加了其他临床试验的临床试验者； 注：凡符合上述任何一条的患者，即应予以排除。

Exclusion criteria：

This experiment is divided into two parts: a study on healthy subjects and a study on patients with peripheral facial nerve palsy. 1. Exclusion criteria for volunteers in the healthy volunteer group (1) Those with a history of craniocerebral trauma or surgery; (2) Patients with neurological diseases such as Parkinson's disease and dementia; (3) Patients with hypertension, diabetes and major heart, liver, kidney and other organ diseases; (4) Those who have pacemakers, stents and other metal objects in their bodies; (5) Those who are afraid or unable to undergo acupuncture, TMS or peripheral nerve electrical stimulation for other reasons; (6) Pregnant person. (7) Patients with severe cerebrovascular, malignant tumors, blood and mental system diseases; (8) Clinical trial participants who also participated in other clinical trials; Note: Patients who meet any of the above conditions should be excluded. 2. 2. Exclusion criteria for peripheral facial paralysis patient group: (1) Those with a history of craniocerebral trauma or surgery; (2) Patients with neurological diseases such as Parkinson's disease and dementia; (3) Patients with hypertension, diabetes and major heart, liver, kidney and other organ diseases; (4) Those who have pacemakers, stents and other metal objects in their bodies; (5) Those who are afraid or unable to undergo acupuncture, TMS or peripheral nerve electrical stimulation for other reasons; (6) Pregnant, perinatal and lactating women; (7) Patients with severe cerebrovascular, malignant tumors, blood and mental system diseases; (8) Clinical trial participants who also participated in other clinical trials; Note: Patients who meet any of the above conditions should be excluded.

研究实施时间：

Study execute time：

从From 2024-08-16

至To      2025-08-16

征募观察对象时间：

Recruiting time：

从From 2024-08-16

至To      2025-01-16

干预措施：

Interventions：

组别：

周围性面神经麻痹患者观察组

样本量：

30

Group：

Observation group for patients with peripheral facial nerve palsy

Sample size：

干预措施：

对外周性面瘫患者的合谷穴进行针刺及电脉冲刺激，并分别在两种刺激前后进行磁刺激诱发电位检测

干预措施代码：

Intervention：

Acupuncture and electrical pulse stimulation were performed on the Hegu point of patients with peripheral facial paralysis, and magnetic stimulation evoked potentials were detected before and after the two stimulations.

Intervention code：

组别：

健康志愿者观察组

样本量：

30

Group：

healthy volunteer observation group

Sample size：

干预措施：

对健康志愿者的合谷穴进行针刺及电脉冲刺激，并分别在两种刺激前后进行磁刺激诱发电位检测

干预措施代码：

Intervention：

Acupuncture and electrical pulse stimulation were performed on the Hegu point of healthy volunteers and magnetic stimulation evoked potentials were detected before and after the two stimulations.

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

陕西

市(区县)：

咸阳

Country：

China

Province：

shaanxi

City：

Xianyang

单位(医院)：

陕西中医药大学第二附属医院

单位级别：

三级甲等

Institution/hospital：

The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Level of the institution：

Class IIIA

测量指标：

Outcomes：

指标中文名：

House-Brackmann量表评分

指标类型：

次要指标

Outcome：

House-Brackmann scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

经颅磁刺激诱发动作电位

指标类型：

主要指标

Outcome：

transcranial magnetic stimulation evoked action potentials

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

本项实验无需采集人体标本

Fate of sample 

Others

Note：

This experiment does not require the collection of human specimens

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 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）：

本研究采取受试者自身对照原则，故无分组，试验的顺序随机，按招募的先后顺序进行 。

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

For healthy volunteers number them according to the expected number of patients to be recruited so that each group is equally assigned to a random number and these number cards are placed in opaque envelopes in shuffled order and then 30 envelopes are mixed and placed in a large Carton each patient will be recruited and the patient himself will draw an envelope from the carton. After each patient who met the inclusion criteria received the envelope he opened the small piece of paper with the number and corresponding treatment written inside. The patients then go to the corresponding treatment department to receive intervention according to the contents of the small piece of paper and then wait until a week later to draw lots again to enter the next group to receive intervention and so on.

盲法：

Blinding：

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）：

http://www.medresman.org.cn/uc/index.aspx

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

http://www.medresman.org.cn/uc/index.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：

数据采集和管理一是通过经颅磁刺激诱发动作电位活动板块采集信息并上传保存在电脑中。二是通过病例记录表收集信息并保存数据并上传至ResMan。

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

Data collection and management: First the information is collected through transcranial magnetic stimulation-induced action potential activity plate and uploaded and saved in the computer. The second is to collect information through the case record form and save the data and upload it to ResMan.

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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