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Concurrent Transcranial Direct Current Stimulation with Cognitive Training for Cognitive Functions of Schizophrenia Patients
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注册号：

Registration number：

 ChiCTR1900025550 

最近更新日期：

Date of Last Refreshed on：

 2019-08-31 23:48:57 

注册时间：

Date of Registration：

 2019-08-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Concurrent Transcranial Direct Current Stimulation with Cognitive Training for Cognitive Functions of Schizophrenia Patients

Public title：

Concurrent Transcranial Direct Current Stimulation with Cognitive Training for Cognitive Functions of Schizophrenia Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Randomised Controlled Trial of Online Transcranial Direct Current Stimulation (tDCS) in Enhancing the Effects of Cognitive Training in patients with Schizophrenia

Scientific title：

A Randomised Controlled Trial of Online Transcranial Direct Current Stimulation (tDCS) in Enhancing the Effects of Cognitive Training in patients with Schizophrenia

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：

Lo Ka Ying Heidi 

研究负责人：

Lo Ka Ying Heidi 

Applicant：

Lo Ka Ying Heidi 

Study leader：

Lo Ka Ying Heidi 

申请注册联系人电话：

Applicant telephone：

 +852 97169237

研究负责人电话：

Study leader's
telephone：

+852 97169237

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：

 lky710@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 lky710@ha.org.hk

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：

9 Chuen On Road, Tai Po, NT, Hong Kong, China

研究负责人通讯地址：

9 Chuen On Road, Tai Po, NT, Hong Kong, China

Applicant address：

9 Chuen On Road, Tai Po, NT, Hong Kong, China

Study leader's address：

9 Chuen On Road, Tai Po, NT, Hong Kong

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：

香港中文大學大埔醫院

Applicant's institution：

Department of Psychiatry, Tai Po Hospital, Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學大埔醫院

Affiliation of the Leader：

Department of Psychiatry, Tai Po Hospital, Chinese University of Hong Kong

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：

 CREC2019.239-T

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-06-28 00:00:00

伦理委员会联系人：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Contact Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

香港中文大學大埔醫院

Primary sponsor：

Tai Po Hospital, Chinese University of Hong Kong

研究实施负责（组长）单位地址：

9 Chuen On Road, Tai Po, NT, Hong Kong, China

Primary sponsor's address：

9 Chuen On Road, Tai Po, NT, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

精神分裂症  

Target disease：

Schizophrenia

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary objective of the study is to investigate the adjunct effect of online tDCS with cognitive training on specific cognitive domains in stable schizophrenia patients. (i) right after the intervention (ii) whether maintenance effect at 1 month after intervention. The secondary objective of the study is to probe (i) any effects on affective , psychotic and negative symptoms; (ii) psychosocial functioning, subjective quality of life (QOL); (iii) the motivation and enjoyment of continuing playing the computerized cognitive training; (iv) the tolerability and adverse events of tDCS among patients with schizophrenia.  

Objectives of Study：

The primary objective of the study is to investigate the adjunct effect of online tDCS with cognitive training on specific cognitive domains in stable schizophrenia patients. (i) right after the intervention (ii) whether maintenance effect at 1 month after intervention. The secondary objective of the study is to probe (i) any effects on affective , psychotic and negative symptoms; (ii) psychosocial functioning, subjective quality of life (QOL); (iii) the motivation and enjoyment of continuing playing the computerized cognitive training; (iv) the tolerability and adverse events of tDCS among patients with schizophrenia.

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. History of significant head trauma;
2. active abuse of alcohol or illegal substances;
3. significant neurologic history such as dementia, stroke, seizure, Parkinsons disease, multiple sclerosis;
4. concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors ;
5. documented history of learning disability;
f. implanted with pacemakers, intracranial electrodes, defibrillators;
g. changes in medication regime over the 2 weeks before or during the study period.

Exclusion criteria：

1. History of significant head trauma;
2. active abuse of alcohol or illegal substances;
3. significant neurologic history such as dementia, stroke, seizure, Parkinsons disease, multiple sclerosis;
4. concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors ;
5. documented history of learning disability;
f. implanted with pacemakers, intracranial electrodes, defibrillators;
g. changes in medication regime over the 2 weeks before or during the study period.

研究实施时间：

Study execute time：

从 From 2019-08-01 00:00:00至 To 2020-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-09-02 00:00:00 至 To 2020-06-30 00:00:00

干预措施：

Interventions：

组别：

Control group

样本量：

 16

Group：

Control Group

Sample size：

干预措施：

Computerised Cognitive Training with sham tDCS stimulation

干预措施代码：

Intervention：

Computerised Cognitive Training with sham tDCS stimulation

Intervention code：

组别：

Concurrent Training Group

样本量：

 16

Group：

Concurrent Training Group

Sample size：

干预措施：

Concurrent Computerised Cognitive Training with active tDCS stimulation

干预措施代码：

Intervention：

Concurrent Computerised Cognitive Training with active tDCS stimulation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

HKSAR

City：

单位(医院)：

 大埔醫院 

单位级别：

 三级甲等 

Institution
hospital：

Tai Po Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

CANTAB

指标类型：

主要指标

Outcome：

CANTAB

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：

N/A

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

The subjects will be randomly allocated to the intervention group or the control group by a block randomization procedure (1:1 allocation) . The randomization sequence will be generated by an online randomization tool (www.sealedenvelop.com) .

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

The subjects will be randomly allocated to the intervention group or the control group by a block randomization procedure (1:1 allocation) . The randomization sequence will be generated by an online randomization tool (www.sealedenvelop.com) .

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Double Blind

Blinding：

Double Blind

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）：

Six months after the trial completed, the data will be shared at the Hong Kong College of Psychiatrists (https://www.hkcpsych.org.hk/index.php?option=com_docman&view=docman&Itemid=354&lang=en)

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

Six months after the trial completed, the data will be shared at the Hong Kong College of Psychiatrists (https://www.hkcpsych.org.hk/index.php?option=com_docman&view=docman&Itemid=354&lang=en)

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：

Raw data and electronic data will be stored in locked space and password protected computers respectively. All data will be destroyed 5 years after completion of study and submission for publication.

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

Raw data and electronic data will be stored in locked space and password protected computers respectively. All data will be destroyed 5 years after completion of study and submission for publication.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-08-31 23:48:58
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