基于静息态脑电信号的脑网络分析探究心脏神经症与焦虑障碍的神经生理相关性

注册号:

Registration number:

ITMCTR2022000066

最近更新日期:

Date of Last Refreshed on:

2022-08-15

注册时间:

Date of Registration:

2022-06-21

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于静息态脑电信号的脑网络分析探究心脏神经症与焦虑障碍的神经生理相关性

Public title:

The Study of the Neurophysiological Correlation Between Cardiac Neurosis and Anxiety Disorders by Brain Network Analysis Based On Resting State EEG Signals

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于静息态脑电信号的脑网络分析探究心脏神经症与焦虑障碍的神经生理相关性

Scientific title:

The Study of the Neurophysiological Correlation Between Cardiac Neurosis and Anxiety Disorders by Brain Network Analysis Based On Resting State EEG Signals

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:

ChiCTR2200062637 ; ChiMCTR2200006478

申请注册联系人:

张成

研究负责人:

张成

Applicant:

Zhang Cheng

Study leader:

Zhang Cheng

申请注册联系人电话:

Applicant telephone:

13401107801

研究负责人电话:

Study leader's telephone:

13401107801

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:

13401107801@163.com

研究负责人电子邮件:

Study leader's E-mail:

13401107801@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:

北京市西城区北线阁街5号

研究负责人通讯地址:

北京市西城区北线阁街5号

Applicant address:

No.5, beixiange, Xicheng District, Beijing

Study leader's address:

No.5, beixiange, Xicheng District, Beijing

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:

中国中医科学院广安门医院

Applicant's institution:

Guang'anmen Hospital of Chinese 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:

2022-052-KY

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:

中国中医科学院广安门医院伦理委员会

Name of the ethic committee:

Ethics Committee, Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/3/18 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

QIAO JIE

伦理委员会联系地址:

北京市西城区北线阁街5号

Contact Address of the ethic committee:

No.5, beixiange, Xicheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-88001552

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

研究实施负责(组长)单位地址:

北京市西城区北线阁街5号

Primary sponsor's address:

No.5, beixiange, Xicheng 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

市(区县):

北京市

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁街5号

Institution
hospital:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

Address:

No.5, beixiange, Xicheng District, Beijing

经费或物资来源:

中国中医科学院科技创新工程

Source(s) of funding:

Scientific and technological innovation project of China Academy of Chinese Medical Sciences

研究疾病:

心脏神经症,焦虑障碍

研究疾病代码:

Target disease:

Cardiac Neurosis , Anxiety Disorders

Target disease code:

研究类型:

Study type:

病因学/相关因素研究

Cause/Relative factors study

研究设计:

Study design:

病例对照研究

Case-Control study

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本课题基于脑电信号为主要研究手段,采用脑电信号的线性和非线性神经成像技术,以与大脑高级认知功能密切相关的静息态脑网络功能连接机制为切入点,选取心脏神经症心肝阴虚证患者为研究对象,分析心脏神经症合并焦虑障碍患者脑网络连接模式的变化规律及时空机制,探究心脏神经症与焦虑状态的神经生理相关性。以期阐明该病反复发作的神经生理学特征。为中药治疗心脏神经症的疗效评价提供新的生物标记物。深化中医“情志理论”脑结构与功能的研究基础。利用脑电信号脑成像技术探索脑与脏腑证候的中枢调节机制,为证候物质基础研究从脑神经生理这一维度提供了新思路。

Objectives of Study:

Cardiac neurosis is a kind of functional cardiovascular disease, and its prevalence has increased significantly in recent years. Psychological cognitive mechanism plays an important role in the pathogenesis of cardiac neurosis, especially for patients with anxiety disorder, its cognitive mechanism may be related to abnormal brain functional integration or abnormal functional connection pattern, which can continuously respond without task stimulation and goal orientation. This subject selects the patients of cardiac neurosis with heart Yin deficiency syndrome as the research object,which has the corresponding research foundation in EEG signals research. The EEG signal is the main research method. By calculating the coupling relationship between EEG signals in different channels, the characteristics of EEG signals reflecting the time-frequency-space characteristics of different brain regions are extracted to analyze the changing rules and space-time mechanism of brain network connection pattern in patients with cardiac neurosis combined with anxiety disorder. and explore the neurophysiological correlation between cardiac neurosis and anxiety disorder. From the perspective of EEG network science to consider the etiology, maintenance and treatment mechanisms of the disease. It can provide a new target for objective evaluation of TCM treatment of cardiac neurosis and screening of effective drugs and mechanism of action. At the same time, from the dimension of EEG functiona

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组: a.符合心脏神经症诊断标准; b.中医辨证主证属心肝阴虚证; c.符合惊恐障碍或广泛性焦虑障碍诊断标准; d.门诊初诊病人,之前未接受系统治疗; e.年龄18-50岁,性别不限; f.右手利。 ②组: a.符合心脏神经症诊断标准; b.中医辨证主证属心肝阴虚证; c.不符合惊恐障碍或广泛性焦虑障碍诊断标准;; d.门诊初诊病人,之前未接受系统治疗; e.年龄18-50岁,性别不限; f.右手利。 ③组: a.符合惊恐障碍或广泛性焦虑障碍诊断标准; b.中医辨证主证属心肝阴虚证; c.不符合心脏神经症诊断标准; d.门诊初诊病人,之前未接受系统治疗; e.年龄18-50岁,性别不限; f.右手利。 ④组: 正常人对照组:选取无神经精神疾病及躯体疾病的健康人自愿者,年龄18-50岁,性别不限;右手利。

Inclusion criteria

Group 1: A: meet the diagnostic criteria of cardiac neurosis; B. The main syndrome of TCM syndrome differentiation is syndrome of deficiency of Heart, liver and Yin; C. Meet the diagnostic criteria for panic disorder or generalized anxiety disorder; D. New outpatient patients who have not received systematic treatment before; E. Age 18-50, regardless of gender; F. Right-handed. Group 2: A. Meet the diagnostic criteria of cardiac neurosis; B. The main syndrome of TCM syndrome differentiation is syndrome of deficiency of Heart, liver and Yin; C. Do not meet the diagnostic criteria for panic disorder or generalized anxiety disorder; D. New outpatient patients who have not received systematic treatment before; E. Age 18-50, regardless of gender; F. Right-handed. Group 3: A: meet the diagnostic criteria of panic disorder or generalized anxiety disorder; B. The main syndrome of TCM syndrome differentiation is syndrome of deficiency of Heart, liver and Yin; C. Does not meet the diagnostic criteria of cardiac neurosis; D. New outpatient patients who have not received systematic treatment before; E. Age 18-50, regardless of gender; F. Right-handed group: normal control Group 4: Hhealthy volunteers without neuropsychiatric and physical diseases, aged 18-50 years old, with no gender limitation; The right hand.

排除标准:

⑴甲状腺功能亢进、嗜络细胞瘤等内分泌与代谢疾病; ⑵器质性心脏病、严重心律失常(如室性心动过速、心室颤动)、心力衰竭等; ⑶精神分裂症、器质性精神障碍、精神活性物质或非成瘾物质所致精神障碍、精神分裂症、心境障碍; ⑷酒精和药物依赖病史; ⑸脑器质性疾病、颅脑外伤史; ⑹肝、肾、脑等重要脏器严重器质性疾病者; ⑺妊娠期和哺乳妇女; ⑻2周内服用精神类药物、神经系统药物。

Exclusion criteria:

A. Endocrine and metabolic diseases such as hyperthyroidism; B. Organic heart disease serious arrhythmia (such as ventricular tachycardia ventricular fibrillation) heart failure; C. Schizophrenia organic mental disorders Mental disorders due to psychoactive substances or non-addictive substances schizophrenia mood disorders; D. History of alcohol and drug dependence; E. Organic brain disease craniocerebral trauma history; F. Serious organic diseases of liver, kidney and brain; G.Pregnant and lactating women; H.Take psychiatric medications or neurological medications for 2 weeks.

研究实施时间:

Study execute time:

From 2021-10-01

To      2024-09-30

征募观察对象时间:

Recruiting time:

From 2022-09-01

To      2024-06-01

干预措施:

Interventions:

组别:

4

样本量:

60

Group:

4

Sample size:

干预措施:

脑电图测量

干预措施代码:

Intervention:

EEG signal measurement

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):

北京市

市(区县):

北京市

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国中医科学院广安门医院

单位级别:

三级甲等

Institution/hospital:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

Level of the institution:

Grade III Level A hospital

测量指标:

Outcomes:

指标中文名:

基于脑电信号的脑网络分析

指标类型:

主要指标

Outcome:

Brain network connection pattern based on EEG signals

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:

脑电信号

组织:

Sample Name:

EEG signals

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 50
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):

病例对照研究,无随机法

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

no

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):

期刊论文

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

Journal Papers

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: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)

数据管理委员会:

Data Managemen Committee:

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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