ChiCTR2600119561 版本V1.0 版本创建时间2026/02/28 15:43:29 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:

ChiCTR2600119561 

最近更新日期:

Date of Last Refreshed on:

2026-02-28 15:43:22 

注册时间:

Date of Registration:

2026-02-28 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

强化学习视角下的强迫行为习得:行为、神经与计算机制研究

Public title:

The behavioral, neural, and computational mechanisms on compulsive behaviour acquisition with the perspective of reinforcement learning

注册题目简写:

English Acronym:

研究课题的正式科学名称:

强化学习视角下的强迫行为习得:行为、神经与计算机制研究

Scientific title:

The behavioral, neural, and computational mechanisms on compulsive behaviour acquisition with the perspective of reinforcement learning

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:

阮中强 

研究负责人:

阳琼 

Applicant:

Zhongqiang Ruan 

Study leader:

Qiong Yang 

申请注册联系人电话:

Applicant telephone:

+86 198 6696 1312

研究负责人电话:

Study leader's
telephone:

+86 137 2537 2097

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:

ruanzq@m.scnu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

15851780@qq.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:

广东省广州市天河区中山大道西55号华南师范大学心理学院

研究负责人通讯地址:

广州市荔湾区明心路36号

Applicant address:

School of Psychology, South China Normal University, No. 55, West of Zhongshan Avenue, Guangzhou, China

Study leader's address:

No. 36, Mingxin Road, Liwan District, Guangzhou, 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:

华南师范大学心理学院

Applicant's institution:

School of Psychology South China Normal University

研究负责人所在单位:

广州医科大学附属脑科医院

Affiliation of the Leader:

The Affiliated Brain Hospital of Guangzhou Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

(2021)第(072)号

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:

广州医科大学附属脑科医院伦理委员会

Name of the ethic committee:

IRB, The Affiliated Brain Hospital of Guangzhou Medical

伦理委员会批准日期:

Date of approved by ethic committee:

2021-11-04 00:00:00

伦理委员会联系人:

杨婵娟

Contact Name of the ethic committee:

Chanjuan Yang

伦理委员会联系地址:

广州市荔湾区明心路36号

Contact Address of the ethic committee:

No. 36, Mingxin Road, Liwan District, Guangzhou, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 8126 8229

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:

广州医科大学附属脑科医院

Primary sponsor:

The Affiliated Brain Hospital of Guangzhou Medical University

研究实施负责(组长)单位地址:

广州市荔湾区明心路36号

Primary sponsor's address:

No. 36, Mingxin Road, Liwan District, Guangzhou, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州医科大学附属脑科医院

具体地址:

广州市荔湾区明心路36号

Institution
hospital:

The Affiliated Brain Hospital of Guangzhou Medical University

Address:

No. 36, Mingxin Road, Liwan District, Guangzhou, China

经费或物资来源:

国家自然科学基金(32171081)

Source(s) of funding:

National Natural Science Foundation of China (32171081)

研究疾病:

强迫症  

Target disease:

Obsessive-Compulsive Disorder

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

研究经颅直流电刺激(tDCS)对强迫症状改善背后的神经认知机制。  

Objectives of Study:

Our research aims to investigate the neurocognitive mechanisms behind the improvement of obsessive-compulsive symptoms through transcranial direct current stimulation (tDCS).

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)OCD 患者:1.符合美国精神障碍诊断与统计手册第五版(DSM-5)对强迫症的诊断标准;2.年龄18-50 周岁;3.汉族;4.右利手;5.受教育年限6年以上(文化程度小学或者小学以上);6.符合MRI检查要求;7.理解研究的内容,希望参加并能够完成整个实验,并签署知情同意书;8.使用《简明国际神经精神访谈》作为访谈工具筛查被试的精神障碍史;9.Y-BOCS总分>=16分,且强迫行为分量表>=10分;10.三个月内无电休克治疗史。 (2)OCD未患病一级亲属:1.必须是OCD患者的兄弟姊妹(不包括其父母或子女);2.未患强迫症或其他精神疾病;3.其余同OCD患者入组标准2-8。 (3)健康对照:1.自己及三代亲属均未患强迫症及其它精神疾病;2.其余同OCD患者入组标准2-8。

Inclusion criteria

(1) OCD patients: 1. Meet the diagnostic criteria for obsessive-compulsive disorder in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in the United States; 2. Age range: 18-50 years old; 3. Han ethnicity; 4. Right-handed hand; 5. Having received at least 6 years of education (with a primary school education or above); 6. Meets the requirements of MRI examination; 7. Understand the research content, hope to participate in and complete the entire experiment, and sign the informed consent form; 8. Using the MINI-International Neuropsychiatric Interview to screen participants' history of mental disorders; 9. The total score of Y-BOCS is >= 16 points, and the compulsive behavior scale is >= 10 points; 10. No history of electroconvulsive therapy within three months. (2) First-degree relatives of patients with OCD: 1. must be siblings of OCD patients (excluding their parents or children); 2. Not suffering from OCD or other mental illnesses; 3. Inclusion criteria for other OCD patients 2-8. (3) Healthy control: 1. Neither oneself nor three generations of relatives suffer from OCD or other mental illnesses; 2. Inclusion criteria for other OCD patients 2-8.

排除标准:

(1)OCD 患者:1.有神经模式疾病史或重大躯体疾病史;2.合并其他精神障碍(如重型抑郁症、精神分裂症、或恐惧症等);3.有酒精和药物滥用或依赖史。 (2)OCD未患病一级亲属:1.有严重躯体疾病或脑器质性疾病或神经模式疾病及其病史;2.有服用药物、酒精或其他影响中枢神经系统功能的物质滥用或依赖史。 (3)健康对照:同OCD未患病一级亲属。

Exclusion criteria:

(1) OCD patients: 1. have a history of neurological pattern disorders or major physical illnesses; 2. Merge other mental disorders (such as major depression, schizophrenia, or phobias); 3. History of alcohol and drug abuse or dependence. (2) First-degree relatives of patients with OCD: 1. have serious physical or brain organic diseases or neurological pattern diseases and their medical history; 2. History of abuse or dependence on drugs, alcohol, or other substances that affect central nervous system function. (3) Healthy control: same as the first-degree relatives of patients with OCD.

研究实施时间:

Study execute time:

From 2021-11-05 00:00:00 To 2022-10-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2021-11-05 00:00:00 To 2022-10-30 00:00:00

干预措施:

Interventions:

组别:

阴极刺激

样本量:

30

Group:

Cathodal stimulation

Sample size:

干预措施:

经颅直流电刺激

干预措施代码:

Intervention:

Transcranial direct current stimulation

Intervention code:

组别:

阳极刺激

样本量:

30

Group:

Anodal stimulation

Sample size:

干预措施:

经颅直流电刺激

干预措施代码:

Intervention:

Transcranial direct current stimulation

Intervention code:

组别:

伪刺激

样本量:

30

Group:

Sham stimulation

Sample size:

干预措施:

经颅直流电刺激

干预措施代码:

Intervention:

Transcranial direct current stimulation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

guangdong

City:

单位(医院):

广州医科大学附属脑科医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Brain Hospital of Guangzhou Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

双系统权重

指标类型:

主要指标

Outcome:

dual system weight

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

仲裁控制

指标类型:

主要指标

Outcome:

arbitration control

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MRI 指标

指标类型:

主要指标

Outcome:

MRI metrics

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:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 50 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):

研究者使用SPSS软件产生随机序列给受试者分组.

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

The researchers used SPSS software to generate a random sequence to group the participants.

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:

该项目主试与受试者双方均不知晓干预分配。

Blinding:

Neither the experimenter nor the subjects were aware of the intervention allocation in this project.

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

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):

https://github.com/allhaillelouch0

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

https://github.com/allhaillelouch0

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:

研究者根据受试者的原始数据,将数据及时、完整、正确记入报告表。 电子数据分类保存。

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

According to the original data of the subjects, the researchers recorded the data in the report form timely, completely and correctly. The electronic data is classified and stored.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-02-28 15:43:22