基于fMRI的抑郁症针刺脑图谱构建研究

注册号:

Registration number:

ITMCTR2025000266

最近更新日期:

Date of Last Refreshed on:

2025-02-14

注册时间:

Date of Registration:

2025-02-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于fMRI的抑郁症针刺脑图谱构建研究

Public title:

The Construction of fMRI-based Acupuncture Brain Mapping for Depression

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于fMRI的抑郁症针刺脑图谱构建研究

Scientific title:

The Construction of fMRI-based Acupuncture Brain Mapping for Depression

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:

赵亚楠

研究负责人:

荣培晶

Applicant:

Yanan Zhao

Study leader:

Peijing Rong

申请注册联系人电话:

Applicant telephone:

18800107425

研究负责人电话:

Study leader's telephone:

13718482149

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:

2578868775@qq.com

研究负责人电子邮件:

Study leader's E-mail:

drrongpj@163.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:

北京市东城区东直门内南小街16号

研究负责人通讯地址:

北京市东城区东直门内南小街16号

Applicant address:

No. 16 Nanxiaojie Dongzhimennei Dongcheng District Beijing China

Study leader's address:

No. 16 Nanxiaojie Dongzhimennei Dongcheng 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:

中国中医科学院针灸研究所

Applicant's institution:

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

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:

IA21-2501-020201

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国科学院自动化研究所生物医学研究伦理审查委员会

Name of the ethic committee:

Ethical Review Committee for Biomedical Research Institute of Automation Chinese Academy of Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/15 0:00:00

伦理委员会联系人:

赵训坡

Contact Name of the ethic committee:

Zhao xunpo

伦理委员会联系地址:

北京市海淀区中关村东路95号

Contact Address of the ethic committee:

No.95 Zhongguancun East Road Haidian District Beijing China

伦理委员会联系人电话:

Contact phone of the ethic committee:

15811188122

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xunpo.zhao@ia.ac.cn

研究实施负责(组长)单位:

中国中医科学院中医临床基础医学研究所

Primary sponsor:

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市东城区东直门内南小街16号

Primary sponsor's address:

No. 16 Nanxiaojie Dongzhimennei Dongcheng District Beijing 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):

北京

市(区县):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

中国中医科学院中医临床基础医学研究所

具体地址:

北京市东城区东直门内南小街16号

Institution
hospital:

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

Address:

No. 16 Nanxiaojie Dongzhimennei Dongcheng District Beijing China

经费或物资来源:

国家中医药管理局中医药传承与创新“百千万”人才工程(岐黄工程)岐黄学者项目

Source(s) of funding:

Qihuang Scholars Program of the One Million Talent Project of TCM Inheritance and Innovation (Qihuang Project) of the State Administration of Traditional Chinese Medicine (SATCM)

研究疾病:

抑郁症

研究疾病代码:

Target disease:

Depression

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:

本研究将纳入 120 例健康受试者(HCs)为观察对象,随机分为 6 组,每组 20 例,接受一种穴位的电针刺激(包括百会、印堂、内关、三阴交、合谷、太冲)。以功能磁共振(fMRI)为检测方法,采集电针刺激状态下的 fMRI 数据,构建针刺脑图谱。

Objectives of Study:

In this study 120 healthy subjects (HCs) were included randomly divided into 6 groups of 20 cases each receiving electroacupuncture stimulation of one kind of acupoints (including Baihui Yintang Neiguan Sanyinjiao Hegu and Taichong). Functional magnetic resonance (fMRI) was used as the detection method to collect fMRI data in the state of electroacupuncture stimulation and construct the acupuncture brain atlas.

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)签署知情同意书,同意参加本研究; 2)年龄 20-39 周岁,右利手; 3)身体健康,无神经、精神系统、心脑血管疾病; 4)无重大外伤及手术史。

Inclusion criteria

1) Signed informed consent to participate in this study; 2) Age 20-39 years old right-handed; 3) Be in good health without neurological psychiatric system cardiovascular or cerebrovascular diseases; (4) No history of major trauma or surgery.

排除标准:

1)具有神经、精神系统疾病病史; 2)具有核磁共振检查禁忌症; 3)头颅磁共振扫描发现明显结构异常者; 4)近三个月内接受针灸治疗者; 5)有酒精或药物滥用、依赖史者; 6)妇女处于妊娠、哺乳期或经期。

Exclusion criteria:

1) Have a history of neurologic and psychiatric disorders; 2) with contraindications to MRI; 3) Those who have obvious structural abnormalities detected by cranial magnetic resonance scanning; 4) Those who have received acupuncture treatment within the last three months; 5) Those with a history of alcohol or drug abuse or dependence; 6) Women in pregnancy lactation or menstruation.

研究实施时间:

Study execute time:

From 2025-02-20

To      2028-02-20

征募观察对象时间:

Recruiting time:

From 2025-02-20

To      2028-02-20

干预措施:

Interventions:

组别:

合谷组

样本量:

20

Group:

hegu group

Sample size:

干预措施:

电刺激右侧合谷穴

干预措施代码:

Intervention:

Electroacupuncture stimulation of the right Hegu point

Intervention code:

组别:

印堂组

样本量:

20

Group:

yintang group

Sample size:

干预措施:

电刺激印堂穴

干预措施代码:

Intervention:

Electroacupuncture stimulation of the yintang point

Intervention code:

组别:

太冲组

样本量:

20

Group:

taichong group

Sample size:

干预措施:

电刺激右侧太冲穴

干预措施代码:

Intervention:

Electroacupuncture stimulation of the right Taichong point

Intervention code:

组别:

三阴交组

样本量:

20

Group:

sanyinjiao group

Sample size:

干预措施:

电刺激右侧三阴交穴

干预措施代码:

Intervention:

Electroacupuncture stimulation of the right Sanyinjiao point

Intervention code:

组别:

百会组

样本量:

20

Group:

baihui group

Sample size:

干预措施:

电刺激百会穴

干预措施代码:

Intervention:

Electroacupuncture stimulation of the baihui point

Intervention code:

组别:

内关组

样本量:

20

Group:

heiguan group

Sample size:

干预措施:

电刺激右侧内关穴

干预措施代码:

Intervention:

Electroacupuncture stimulation of the right Neiguan point

Intervention code:

样本总量 Total sample size : 120

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):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

北京市中关村医院

单位级别:

二级甲等

Institution/hospital:

Beijing Zhongguancun Hospital

Level of the institution:

Secondary

测量指标:

Outcomes:

指标中文名:

功能磁共振数据

指标类型:

附加指标

Outcome:

Functional Magnetic Resonance Images

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠指数量表

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Index Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疲劳评定量表

指标类型:

次要指标

Outcome:

Fatigue Assessment Instrument

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

次要指标

Outcome:

Self-rating Anxiety scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

马萨诸塞医院针刺感觉量表

指标类型:

附加指标

Outcome:

Massachusetts General Hospital Acupuncture Sensation Scale

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14项汉密尔顿焦虑量表

指标类型:

次要指标

Outcome:

14 Item Hamilton Anxiety Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

次要指标

Outcome:

Self-rating depression scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

17项汉密尔顿抑郁量表

指标类型:

主要指标

Outcome:

17 Item Hamilton Depression Scale

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:

组织:

Sample Name:

-

Tissue:

人体标本去向

使用后销毁

说明

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 20
Min age years
最大 39
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):

由计算机生成随机序列,患者入组后,采用区组随机的方法进行不同的穴位刺激干预,保证每组20例,共6组。

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

A randomized sequence was generated by computer and after patients were enrolled different acupoint stimulation interventions were carried out using zone group randomization to ensure 20 cases in each group with a total of 6 groups.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

不涉及

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

NO

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

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统