ChiCTR2200062142 版本V1.1 版本创建时间2023/04/02 16:45:43 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：

 ChiCTR2200062142 

最近更新日期：

Date of Last Refreshed on：

 2022-07-25 00:24:46 

注册时间：

Date of Registration：

 2022-07-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Quantitative Electroencephalography-Guided tDCS Intervention in Negative Emotion and Fear Extinction during Covid-19 Pandemic

Public title：

Quantitative Electroencephalography-Guided tDCS Intervention in Negative Emotion and Fear Extinction during Covid-19 Pandemic

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Quantitative Electroencephalography-Guided tDCS Intervention in Negative Emotion and Fear Extinction during Covid-19 Pandemic

Scientific title：

Quantitative Electroencephalography-Guided tDCS Intervention in Negative Emotion and Fear Extinction during Covid-19 Pandemic

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：

Tania Alexandra Zhang- Couto 

研究负责人：

Zhen Yuan 

Applicant：

Tania Alexandra Zhang - Couto 

Study leader：

Zhen Yuan 

申请注册联系人电话：

Applicant telephone：

 +85256825792

研究负责人电话：

Study leader's
telephone：

+853 8822 4989

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：

 yb87605@umac.mo

研究负责人电子邮件：

Study leader's E-mail：

 zhenyuan@umac.mo

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：

16 Fo Chun Road, Solaria, Tower 10, 15 E, Tai Po district, Hong Kong SAR

研究负责人通讯地址：

E12-1047 / E12-1032/1036 FHS University of Macau

Applicant address：

Hong Kong

Study leader's address：

E12-1047 / E12-1032/1036 FHS University of Macau

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：

University of Macau; Chinese University of Hong Kong

Applicant's institution：

University of Macau; Chinese University of Hong Kong

研究负责人所在单位：

Faculty of Health Sciences; University of Macau

Affiliation of the Leader：

Faculty of Health Sciences; University of Macau

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 BSERE21-APP025-ICI

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：

RESEARCH COMMITTEE – PANEL ON RESEARCH ETHICS Sub-Panel on Biomedical Science & Engineering Research Ethics (Human Participants)

Name of the ethic committee：

RESEARCH COMMITTEE – PANEL ON RESEARCH ETHICS Sub-Panel on Biomedical Science & Engineering Research Ethics (Human Participants)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-23 00:00:00

伦理委员会联系人：

Drina Wu

Contact Name of the ethic committee：

Drina Wu

伦理委员会联系地址：

University of Macau, N6, Avenida da Universidade, Taipa, Macau

Contact Address of the ethic committee：

Avenida da Universidade

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +85388224989

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 zhenyuan@um.edu.mo

研究实施负责（组长）单位：

Macao Science and Technology Development Fund

Primary sponsor：

Macao Science and Technology Development Fund

研究实施负责（组长）单位地址：

Avenida Infante D. Henrique , no 43-53A, EDF. The Macau Square, 8th Floor C, and 11th floor K, Macau SAR , China

Primary sponsor's address：

Avenida Infante D. Henrique , no 43-53A, EDF. The Macau Square, 8th Floor C, and 11th floor K, Macau SAR , 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)：

澳门特别行政区

市(区县)：

氹仔

Country：

China

Province：

Macau SAR

City：

Taipa

单位(医院)：

澳门科技发展基金[FDCT 0020/2019/AMJ及FDCT 0011/2018/A1]

具体地址：

Institution
hospital：

Macao Science and Technology Development Fund [FDCT 0020/2019/AMJ and FDCT 0011/2018/A1]

Address：

国家：

中国

省(直辖市)：

澳门特别行政区

市(区县)：

氹仔

Country：

China

Province：

Macau SAR

City：

Taipa

单位(医院)：

澳门大学

具体地址：

澳门大学N6

Institution
hospital：

University of Macau

Address：

University of Macau, N6

经费或物资来源：

[FDCT 0020/2019/AMJ and FDCT 0011/2018/A1]; [MYRG 2020-00067-FHS, MYRG2019-00082- FHS and MYRG2018-00081-FHS];

Source(s) of funding：

[FDCT 0020/2019/AMJ and FDCT 0011/2018/A1]; [MYRG 2020-00067-FHS, MYRG2019-00082- FHS and MYRG2018-00081-FHS];

研究疾病：

Anxiety and Depression disorders  

Target disease：

Anxiety and Depression disorders

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：

 II期临床试验 

Study phase：

2

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

This study aims to use qEEG-guided tDCS to inspect the therapeutic effect of tDCS intervention on patients who suffer from anxiety-depression comorbidity deterioration amid the COVID-19 pandemic in HK SAR. In particular, the impact of tDCS intervention on qEEG spectral power activity and resting-state connectivity organization during eyes closed and eyes open protocols will be examined.  

Objectives of Study：

This study aims to use qEEG-guided tDCS to inspect the therapeutic effect of tDCS intervention on patients who suffer from anxiety-depression comorbidity deterioration amid the COVID-19 pandemic in HK SAR. In particular, the impact of tDCS intervention on qEEG spectral power activity and resting-state connectivity organization during eyes closed and eyes open protocols will be examined.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

The patients' group receive 10-session tDCS once a week for 10 weeks. The 10-session tDCS intervention per week is carried out for two protocols including the negative emotion modulation and fear extinction. The intervention is performed using a battery-powered stimulator (Activadose, Caputron, United States) with two approximately 4 × 4 cm rubber electrodes coated with electrode conductive gel and saline water. After the third and last qEEG data collection, the results are discussed in detail with each participant. In addition, we provide a set of cognitive-behavior therapy strategies combining the approach from the second and third generations to work on the maintenance of the improvements. The same follow-up procedure is implemented with the control group adjusted according to the severity of the symptoms; however, only the clinical group is submitted to a monthly-follow up scheme starting from the end of the qEEG-guided tDCS study. 

纳入标准：

Male or female between the age of 20 and 45 with a history of anxiety and depressive symptoms that cause significant distress or impairment in functioning, right-handed (except two left-handed patients), English proficient speakers, normal and corrected-to-normal vision, and no history of neurological disorders. All participants are proficient bilinguals (living and working in an English speaking country) and learned English as a second language (L2).

Inclusion criteria

Male or female between the age of 20 and 45 with a history of anxiety and depressive symptoms that cause significant distress or impairment in functioning, right-handed (except two left-handed patients), English proficient speakers, normal and corrected-to-normal vision, and no history of neurological disorders. All participants are proficient bilinguals (living and working in an English speaking country) and learned English as a second language (L2).

排除标准：

The exclusion criteria include the presence of substance use, general medical conditions, and symptoms that are better explained by bereavement.

Exclusion criteria：

The exclusion criteria include the presence of substance use, general medical conditions, and symptoms that are better explained by bereavement.

研究实施时间：

Study execute time：

从 From 2022-09-01 00:00:00至 To 2029-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-01 00:00:00 至 To 2027-09-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 12

Group：

clinical group

Sample size：

干预措施：

tDCS

干预措施代码：

Intervention：

tDCS

Intervention code：

组别：

对照组

样本量：

 8

Group：

control group

Sample size：

干预措施：

qEEG

干预措施代码：

Intervention：

qEEG

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国香港

省(直辖市)：

 香港特别行政区 

市(区县)：

 香港岛 

Country：

Hong Kong, China

Province：

Hong Kong SAR

City：

HK island

单位(医院)：

 阿尔法健康诊所 

单位级别：

 脑电图诊所 

Institution
hospital：

Alpha Wellness Clinic

Level of the institution：

EEG clinic

测量指标：

Outcomes：

指标中文名：

神经调节效应-消极情绪

指标类型：

主要指标

Outcome：

neuromodulation Effect - Negative emotion

Type：

Primary indicator

测量时间点：

5次tDCS，每周一次，持续5周

测量方法：

静息态网络（EEG）

Measure time point of outcome：

5-session tDCS, once a week for 5 weeks

Measure method：

resting state networks (EEG)

指标中文名：

神经调节效应——恐惧

指标类型：

主要指标

Outcome：

neuromodulation Effect - Fear

Type：

Primary indicator

测量时间点：

5次tDCS，每周一次，持续5周

测量方法：

静息态网络（EEG）

Measure time point of outcome：

5-session tDCS, once a week for 5 weeks

Measure method：

resting state networks (EEG)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

网络

组织：

大脑

Sample Name：

networks

Tissue：

brain

人体标本去向

 使用后销毁  

说明

5年

Fate of sample：

Destruction after use  

Note：

5 years

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 18 岁 years
最大 Max age 45 岁 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）：

Non-Randomized controlled trial

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

Non-Randomized controlled trial

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：

Blinding：

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）：

N/a

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

N/a

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：

All personal data will be kept strictly confidential. They will be stored separately in a password-protected file and will be securely disposed of as soon as it is no longer necessary and within five years. The co-investigator and principal investigator will be the custodian of the personal data during and after the study. During the study, only the chief investigator and co-investigator involved in the present project can access the personal data for research purposes only.

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

All personal data will be kept strictly confidential. They will be stored separately in a password-protected file and will be securely disposed of as soon as it is no longer necessary and within five years. The co-investigator and principal investigator will be the custodian of the personal data during and after the study. During the study, only the chief investigator and co-investigator involved in the present project can access the personal data for research purposes only.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-07-25 00:24:40