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一项经颅直流电刺激治疗儿童孤独症谱系障碍临床研究
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注册号:

Registration number:

ChiCTR1800015264 

最近更新日期:

Date of Last Refreshed on:

2018-03-19 

注册时间:

Date of Registration:

2018-03-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项经颅直流电刺激治疗儿童孤独症谱系障碍临床研究 

Public title:

A clinical research of transcranial direct current stimulation in the treatment for children with autism spectrum disorders 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经颅直流电刺激治疗儿童孤独症谱系障碍临床研究 

Scientific title:

Clinical research of transcranial direct current stimulation in the treatment for children with autism spectrum disorders 

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:

苏嘉颐 

研究负责人:

邱久军 

Applicant:

Jiayi Su 

Study leader:

Qiu jiujun 

申请注册联系人电话:

Applicant telephone:

+86 13823352175 

研究负责人电话:

Study leader's telephone:

+86 15989333247 

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:

294520443@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1620755022@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:

广东省深圳市福田区福强路3012号深圳市妇幼保健院3栋1楼儿童心理与康复科 

研究负责人通讯地址:

广东省深圳市福田区福强路3012号深圳市妇幼保健院3栋1楼儿童心理与康复科 

Applicant address:

3012 Fuqiang Road, FuTian District, Shenzhen, Guangdong, China 

Study leader's address:

3012 Fuqiang Road, FuTian District, Shenzhen, Guangdong, 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:

深圳市妇幼保健院 

Applicant's institution:

Shenzhen Maternal and Child Healthcare 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:

2017-90 

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:

深圳市妇幼保健院医学伦理委员会 

Name of the ethic committee:

Shenzhen Maternal and Child Healthcare Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-22 

伦理委员会联系人:

张建明 

Contact Name of the ethic committee:

Jianming Zhang 

伦理委员会联系地址:

深圳市红荔路2004号 

Contact Address of the ethic committee:

2004 Hongli Road, Futian District, Shenzhen, Guangdong, 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:

深圳市妇幼保健院,儿童心理与康复科 

Primary sponsor:

Shenzhen Maternal and Child Healthcare Hospital, Child mental health and rehabilitation center 

研究实施负责(组长)单位地址:

广东省深圳市福田区福强路3012号深圳市妇幼保健院3栋1楼儿童心理与康复科 

Primary sponsor's address:

3012 Fuqiang Road, FuTian District, Shenzhen, Guangdong, 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):

广东省

市(区县):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市妇幼保健院

具体地址:

福田区福强路3012号

Institution
hospital:

Shenzhen Maternal and Child Healthcare Hospital

Address:

3012 Fuqiang Road, FuTian District, Shenzhen, China

经费或物资来源:

深圳市三名工程项目 

Source(s) of funding:

Sanming Project of Medicine in Shenzhen 

研究疾病:

孤独症谱系障碍 

Target disease:

Autism spectrum 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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

了解经颅直流电刺激治疗儿童孤独症谱系障碍临床疗效及其脑神经影像等的变化  

Objectives of Study:

To understand the clinical efficacy of transcranial direct current stimulation for children with autism spectrum disorders.  

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DSM-V孤独症谱系障碍的诊断标准;2.右利手。  

Inclusion criteria

1. Meet the diagnostic criteria for dsm-v autism spectrum disorders; 2. Right hand.  

排除标准:

近三个月使用过神经学、激素、或免疫学治疗;患有精神疾病(如精神分裂症等)、遗传代谢性疾病、严重神经疾病以及颅脑损伤史;颅内或体内有植入物或其他情况导致无法完成神经影像学和神经电生理检测;治疗过程中无法遵守医嘱或协议;  

Exclusion criteria:

The use of neurologic, hormone, or immunological therapy in nearly three months;Suffering from mental illness (such as schizophrenia, etc.), hereditary metabolic diseases, severe neurological diseases, and craniocerebral injury history; Intracranial or other intracranial implants or other conditions lead to the inability to complete neuroimaging and neuroelectrophysiological tests; Unable to observe medical advice or agreement during treatment.  

研究实施时间:

Study execute time:

From2018-04-01To 2019-04-30 

征募观察对象时间:

Recruiting time:

From2018-04-01To 2019-04-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

20

Group:

therapy group

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:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

假性经颅直流电刺激

干预措施代码:

Intervention:

Sham 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 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Maternal and Child Healthcare Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

社交行为表现

指标类型:

主要指标 

Outcome:

Autism Social behavior

Type:

Primary indicator 

测量时间点:

治疗前,后

测量方法:

异常行为检查表+重复刻板行为量表+CARS量表

Measure time point of outcome:

pre and post treatment

Measure method:

Aberrant Behavior Checklist+Repeat stereotyped behavior scale+CARS

指标中文名:

儿童睡眠状况

指标类型:

次要指标 

Outcome:

Sleep status of children

Type:

Secondary indicator 

测量时间点:

治疗前,后

测量方法:

儿童睡眠习惯问卷

Measure time point of outcome:

pre and post treatment

Measure method:

Children's sleep habits questionnaire

指标中文名:

眼动

指标类型:

次要指标 

Outcome:

eye-tracking

Type:

Secondary indicator 

测量时间点:

治疗前,后

测量方法:

眼动仪

Measure time point of outcome:

pre and post treatment

Measure method:

eye-tracking

指标中文名:

孤独症诊断标准

指标类型:

次要指标 

Outcome:

Diagnostic criteria for autism

Type:

Secondary indicator 

测量时间点:

治疗前,后

测量方法:

孤独症诊断观察量表

Measure time point of outcome:

pre and post treatment

Measure method:

Autism Diagnostic Observation Schedule

指标中文名:

副反应

指标类型:

副作用指标 

Outcome:

Treatment Emergent Sympton

Type:

Adverse events 

测量时间点:

治疗前,中,后

测量方法:

副反应量表

Measure time point of outcome:

pre,mid and post treatment

Measure method:

Treatment Emergent Sympton Scale

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

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 2 years
最大 Max age 6 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):

随机单盲对照法(由统计师用R产生随机)

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

permitted block randomization(by the statisticians with R generated random)

盲法:

Blinding:

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):

在试验结束后,即2019年10月31日以后公开,通过病例报告表的形式公开。

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

After the end of the trial, that is, Oct 31, 2019, through the form of a case report.

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:

数据采用临床试验病例报告表进行收集,调查表数据采用软件Microsoft Office Excel 2007进行录入管理,运用统计软件SPSS Statistics 19.0进行分析。

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

Data were collected by clinical trial report form, and the questionnaire data were recorded and managed by software Office Excel Microsoft 2007, and the statistical software SPSS Statistics 19.0 was used to analyze the data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-03-19
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