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间歇脉冲刺激(iTBS)联合工作记忆训练改善精神分裂症认知功能的随机对照研究
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注册号:

Registration number:

ChiCTR1900023405 

最近更新日期:

Date of Last Refreshed on:

2020-05-03 

注册时间:

Date of Registration:

2019-05-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

间歇脉冲刺激(iTBS)联合工作记忆训练改善精神分裂症认知功能的随机对照研究  

Public title:

Intermittent pulse stimulation (ITBs) combined with working memory training to improve cognitive function in schizophrenia: a randomized controlled study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

间歇脉冲刺激(iTBS)联合工作记忆训练改善精神分裂症认知功能的随机对照研究  

Scientific title:

Intermittent pulse stimulation (ITBs) combined with working memory training to improve cognitive function in schizophrenia: a randomized controlled study 

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:

宋佳起 

研究负责人:

谭淑平 

Applicant:

Jiaqi Song 

Study leader:

Shuping Tan 

申请注册联系人电话:

Applicant telephone:

+86 18500907374 

研究负责人电话:

Study leader's telephone:

+86 010-83024485 

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:

350800271@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

shupingtan@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:

北京昌平区北京回龙观医院 

研究负责人通讯地址:

北京昌平区北京回龙观医院 

Applicant address:

Beijing Huilongguan Hospital, Changping District, Beijing 

Study leader's address:

Beijing Huilongguan Hospital, Changping 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:

北京回龙观医院 

Applicant's institution:

Beijing Huilongguan Hospital 

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:

2018-36-科-修1 

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:

北京回龙观医院伦理委员会 

Name of the ethic committee:

Beijing Huilongguan Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-18 

伦理委员会联系人:

辛衍涛 

Contact Name of the ethic committee:

Yantao Xin 

伦理委员会联系地址:

北京昌平区北京回龙观医院 

Contact Address of the ethic committee:

Beijing Huilongguan Hospital, Changping District, Beijing,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:

北京回龙观医院 

Primary sponsor:

Beijing Huilongguan Hospital 

研究实施负责(组长)单位地址:

北京昌平区北京回龙观医院 

Primary sponsor's address:

Beijing Huilongguan Hospital, Changping District, Beijing,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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京回龙观医院

具体地址:

北京昌平区北京回龙观医院

Institution
hospital:

Beijing Huilongguan Hospital

Address:

Beijing Huilongguan Hospital, Changping District, Beijing, China

经费或物资来源:

政府经费 

Source(s) of funding:

Government Funding 

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:

探索性研究/预试验 

Study phase:

研究目的:

探索间歇脉冲刺激(iTBS)联合工作记忆训练(WMT)改善精神分裂症患者认知功能的疗效,同时结合神经影像学研究,探讨其神经机制。 

Objectives of Study:

To explore the efficacy of intermittent theta burst stimulation (iTBS) combined with working memory training (WMT) in improving cognitive function in patients with schizophrenia, and to explore its neural mechanism in combination with neuroimaging studies. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、符合精神障碍诊断统计手册第四版(DSM-Ⅳ)精神分裂症的诊断标准;2、PANSS阳性量表单项分<5分,阳性量表总分<22分;3、年龄18-45岁、接受过5年以上正规教育;4、患者自愿参与研究,并签知情同意书;5、既往一个月和估计今后一个月药物种类、剂量不需调整;6、存在认知损害:数字倒背广度=<6; 7、右利手,采用爱丁堡利手评价量表确定。 

Inclusion criteria

1. Comply with the Diagnostic Criteria for Mental Disorders Diagnostic Statistics Manual (DSM-IV) for schizophrenia; 2. PANSS positive amount form item score <5 points, positive scale total score <22 points; 3. Aged 18-45 Years, received more than 5 years of formal education; 4. patients volunteered to participate in the study, and signed informed consent; 5. the past month and estimated the next month the drug types, doses do not need to be adjusted; 6. the existence of cognitive damage: the number down Back breadth = <6; 7. right hand, using the Edinburgh hand evaluation scale to determine. 

排除标准:

1、伴精神发育迟滞或脑器质性疾病患者;2、严重衰退或冲动兴奋不合作;3、伴发严重的抑郁、焦虑和物质滥用;4、存在听觉或/视觉感知障碍;5、严重的躯体疾病或药物副作用,无法进行认知训练;6、孕期或哺乳期妇女;7、体内金属异物等不宜进行MRI扫描。 

Exclusion criteria:

1, with mental retardation or brain organic disease; 2, severe decline or impulsive excitement; 3, accompanied by severe depression, anxiety and substance abuse; 4, there are hearing or / visual perception disorders; 5, serious Physical illness or side effects of drugs, unable to carry out cognitive training; 6, pregnant or lactating women; 7, metal foreign bodies in the body should not be MRI scan. 

研究实施时间:

Study execute time:

From2018-09-01To 2021-08-31 

征募观察对象时间:

Recruiting time:

From2019-06-01To 2021-08-31 

干预措施:

Interventions:

组别:

1

样本量:

50

Group:

1

Sample size:

干预措施:

间歇脉冲刺激合并工作记忆训练

干预措施代码:

Intervention:

iTBS+WMT

Intervention code:

组别:

2

样本量:

50

Group:

2

Sample size:

干预措施:

间歇脉冲刺激合并简单反应训练

干预措施代码:

Intervention:

iTBS+SRT

Intervention code:

组别:

3

样本量:

50

Group:

3

Sample size:

干预措施:

伪间歇脉冲刺激合并工作记忆训练

干预措施代码:

Intervention:

sham-iTBS+WMT

Intervention code:

组别:

4

样本量:

50

Group:

4

Sample size:

干预措施:

伪刺激脉冲刺激合并简单反应训练

干预措施代码:

Intervention:

sham-iTBS+SRT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京回龙观医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Huilongguan Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

安宁医院 

单位级别:

三级医院 

Institution
hospital:

Anning Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

MATRICS共识认知成套测验

指标类型:

主要指标 

Outcome:

MATRICS Consensus Cognitive Battery, MCCB

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阳性与阴性症状量表

指标类型:

次要指标 

Outcome:

Positive And Negative Syndrome Scale, PANSS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简明阴性症状量表

指标类型:

次要指标 

Outcome:

Brief Negative Symptom Scale, BNSS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

个人与社会表现量表

指标类型:

次要指标 

Outcome:

Personal and Social Performance Scale, PSP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

次要指标 

Outcome:

Schizophrenia Quality Of Life Scale, SQOL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自尊量表

指标类型:

次要指标 

Outcome:

Self-Esteem Scale, SES

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

时间性快感体验量表

指标类型:

次要指标 

Outcome:

Temporal Experience of Pleasure Scale, TEPS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

灰质、白质形态结构参数

指标类型:

次要指标 

Outcome:

Morphological structure parameters of gray matter and white matter

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能可塑性参数

指标类型:

次要指标 

Outcome:

Functional plasticity parameters

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物副作用量表

指标类型:

副作用指标 

Outcome:

Treatment Emergent Symptom Scale

Type:

Adverse events 

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:

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 years
最大 Max age 45 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):

根据本研究设计,随机、双盲、伪刺激对照研究,4组之间比例为1:1:1:1,对受试者入组顺序进行随机分配至4组,采用区组随机化。本研究拟共纳入200例受试者,其中北京回龙观医院120例,沈阳安宁医院80例,使用R程序进行随机,随机程序保存为当天时间,随机程序为可重复的。

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

According to the design of this study, randomized, double-blind, sham stimuli control group, clinical trial is conducted. The ratio between the four groups is 1:1:1:1, and the subjects are randomly assigned to the four groups, using blocked randomization. A total of 200 subjects are included in the study, i

盲法:

双盲

Blinding:

Double-blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

项目组根据研究进程择期选择具体方式公开原始数据

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

Accroding to the progress of the research, raw research data should be made freely available to all researchers in specific ways

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观察记录,将数据及时、完整、正确、清晰地载入病例报告表。录入采用相应的数据库系统双人双机录入,之后对数据库进行两遍比对。电子数据文件分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏。

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

Based on the original observations records, researchers will completely write accurate data into case report forms in time. Input the data into corresponding database system by two special researchers with two computers respectively. After that, researchers compare two database twice and electronic data will be conserved and backup.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-25
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