反应抑制在抑郁症青少年非自杀性自伤行为中的作用及电生理机制

注册号:

Registration number:

ChiCTR2600125029 

最近更新日期:

Date of Last Refreshed on:

2026-05-20 14:38:33 

注册时间:

Date of Registration:

2026-05-20 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

反应抑制在抑郁症青少年非自杀性自伤行为中的作用及电生理机制

Public title:

The role and electrophysiological mechanism of response inhibition in non-suicidal self-injury behaviors of adolescents with depression

注册题目简写:

English Acronym:

研究课题的正式科学名称:

反应抑制在抑郁症青少年非自杀性自伤行为中的作用及电生理机制

Scientific title:

The role and electrophysiological mechanism of response inhibition in non-suicidal self-injury behaviors of adolescents with depression

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:

陈方方 

研究负责人:

陈方方 

Applicant:

Fangfang Chen 

Study leader:

Fangfang Chen 

申请注册联系人电话:

Applicant telephone:

+86 182 2553 8625

研究负责人电话:

Study leader's
telephone:

+86 182 2553 8625

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:

spychen1992@126.com

研究负责人电子邮件:

Study leader's E-mail:

spychen1992@126.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:

中国安徽省芜湖市弋江区乌霞山东路1号

研究负责人通讯地址:

中国安徽省芜湖市弋江区乌霞山东路1号

Applicant address:

1 Wuxia Shandong Road, Yijiang District, Wuhu, Anhui, China

Study leader's address:

1 Wuxia Shandong Road, Yijiang District, Wuhu, Anhui, China

申请注册联系人邮政编码:

Applicant postcode:

241000

研究负责人邮政编码:

Study leader's postcode:

241000

申请人所在单位:

芜湖市第四人民医院

Applicant's institution:

Fourth People's Hospital of Wuhu

研究负责人所在单位:

芜湖市第四人民医院

Affiliation of the Leader:

Fourth People's Hospital of Wuhu

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:

[2024]-KY-57

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:

芜湖市第四人民医院医学研究伦理委员会

Name of the ethic committee:

Medical Research Ethics Committee of the Fourth People's Hospital of Wuhu

伦理委员会批准日期:

Date of approved by ethic committee:

2024-10-24 00:00:00

伦理委员会联系人:

张军

Contact Name of the ethic committee:

Jun Zhang

伦理委员会联系地址:

中国安徽省芜湖市弋江区乌霞山东路1号

Contact Address of the ethic committee:

1 Wuxia Shandong Road, Yijiang District, Wuhu, Anhui, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 182 2553 8625

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:

芜湖市第四人民医院

Primary sponsor:

Fourth People's Hospital of Wuhu

研究实施负责(组长)单位地址:

中国安徽省芜湖市弋江区乌霞山东路1号

Primary sponsor's address:

1 Wuxia Shandong Road, Yijiang District, Wuhu, Anhui, 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):

安徽

市(区县):

芜湖

Country:

China

Province:

Anhui

City:

Wuhu

单位(医院):

芜湖市第四人民医院

具体地址:

中国安徽省芜湖市弋江区乌霞山东路1号

Institution
hospital:

Fourth People's Hospital of Wuhu

Address:

1 Wuxia Shandong Road, Yijiang District, Wuhu, Anhui, China

经费或物资来源:

安徽省卫健委;安定医院芜湖医院(芜湖市第四人民医院)

Source(s) of funding:

Anhui Provincial Health Commission, Anding Hospital Wuhu Hospital (The Fourth People's Hospital)

研究疾病:

抑郁症伴非自杀性自伤行为  

Target disease:

MDD with non-suicidal self-injury

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:

探索阳极tDCS刺激右侧额下回改善伴NSSI行为抑郁症青少年对负性情绪反应抑制缺陷的效果评估  

Objectives of Study:

To explore the effect of anodic tDCS stimulation on the right inferior frontal gyrus in improving the deficiency of negative emotional response inhibition in adolescents with behavioral depression accompanied by NSSI

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

(1)脑损伤及其他重大躯体疾病; (2)精神发育迟滞、癫痫等重大神经系统疾病; (3)曾接受过MECT、rTMS、tACS等物理干预和心理干预者。

Exclusion criteria:

(1) Brain injury and other major physical diseases; (2) Mental retardation, epilepsy, and other major neurological disorders; (3) Those who have previously received physical interventions such as MECT, rTMS, tACS, as well as psychological interventions.

研究实施时间:

Study execute time:

From 2026-06-01 00:00:00 To 2028-04-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-01 00:00:00 To 2028-03-30 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

30

Group:

Intervention group

Sample size:

干预措施:

阳极tDCS刺激右侧IFG

干预措施代码:

A-tDCS

Intervention:

Anode tDCS stimulates the right IFG

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

假刺激

干预措施代码:

S-tDCS

Intervention:

Sham stimulation tDCS stimulation right IFG

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

安徽 

市(区县):

芜湖 

Country:

China

Province:

Anhui

City:

Wuhu

单位(医院):

芜湖市第四人民医院 

单位级别:

三甲 

Institution
hospital:

Fourth People's Hospital of Wuhu

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

青少年自我伤害问卷

指标类型:

主要指标

Outcome:

Adolescent Self-Harm Behavior Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

情绪性Go/No-Go任务

指标类型:

主要指标

Outcome:

Emotional Go/No-Go tasks

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标

Outcome:

Hamilton 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:

情绪反应性量表

指标类型:

次要指标

Outcome:

Emotion Reactivity Scale

Type:

Secondary 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 18 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):

由随机员使用随机数列生成器产生随机数列,该数列生成后由随机员统一保管,并在符合入组标准的被试入组时按照随机号进行随机分组

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

The random number sequence is generated by the random number generator by the random number generator, and the random number is stored by the random officer after the generation of the random number and randomized according to the random number when the subjects who meet the enrollment criteria are enrolled.

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:

评估者盲

Blinding:

Evaluator blindness

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

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):

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

None

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:

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

None

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:

 2026-05-20 14:38:27