今天是:2019-06-20 星期四

非侵入性脑刺激技术治疗儿童发育性口吃的作用与机制
下载XML文档

注册号:

Registration number:

ChiCTR1900022544 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

非侵入性脑刺激技术治疗儿童发育性口吃的作用与机制 

Public title:

The role and mechanism of non-invasive brain stimulation (NIBS) for children who stutter 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

非侵入性脑刺激技术治疗儿童发育性口吃的作用与机制 

Scientific title:

The role and mechanism of non-invasive brain stimulation (NIBS) for children who stutter 

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:

洪小霞 

研究负责人:

徐开寿 

Applicant:

Xiaoxia Hong 

Study leader:

Kaishou Xu 

申请注册联系人电话:

Applicant telephone:

+86 18825075910 

研究负责人电话:

Study leader's telephone:

+86 13422250582 

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:

nikihxx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xksyi@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:

广州市越秀区人民中路318号 

研究负责人通讯地址:

广州市越秀区人民中路318号 

Applicant address:

318 Middle Renmin Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

318 Middle Renmin Road, Yuexiu District, Guangzhou, 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:

广州市妇女儿童医疗中心 

Applicant's institution:

Guangzhou Women and Children's Medical Center 

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:

穗妇儿 科伦 通字[2019] 第10300号 

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:

广州市妇女儿童医疗中心科研伦理委员会 

Name of the ethic committee:

Scientific Research Ethics Committee of Guangzhou Women and Children's Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-05 

伦理委员会联系人:

李敏清 

Contact Name of the ethic committee:

Minqing Li 

伦理委员会联系地址:

广州市天河区金穗路9号医务部 

Contact Address of the ethic committee:

Medical Department, 9 Jinsui Road, Guangzhou, 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:

广州市妇女儿童医疗中心 

Primary sponsor:

Guangzhou Women and Children's Medical Center 

研究实施负责(组长)单位地址:

广州市越秀区人民中路318号 

Primary sponsor's address:

318 Middle Renmin Road, Yuexiu District, Guangzhou, 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

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州市妇女儿童医疗中心

具体地址:

广州市越秀区人民中路318号

Institution
hospital:

Guangzhou Women and Children's Medical Center

Address:

318 Middle Renmin Road, Yuexiu District, Guangzhou

经费或物资来源:

广州市妇女儿童医疗中心 

Source(s) of funding:

Guangzhou Women and Children's Medical Center 

研究疾病:

发育性口吃 

Target disease:

developmental stuttering 

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:

探讨NIBS结合常规康复训练对患儿言语流畅性的作用,进而阐述NIBS治疗发育性口吃患儿的神经机制,确定最佳的刺激部位,为优化发育性口吃的治疗方案提供依据。 

Objectives of Study:

To investgate the role of non-invasive brain stimulation (NIBS) and conventional rehabilitation with speech fluency for children who stuttering, and hope to elaborate the mechanism of NIBS in the treatment of developmental stuttering, and to determine the optimal stimulation site, so as to provide an envidence-based treatment for developmental stuttering. 

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诊断为发育性口吃; ②年龄4-16岁; ③男性; ④以中文作为第一语言 

Inclusion criteria

1. Be diagnosed as developmental stutter; 2. aged 4-16 years; 3. Men; 4. Native Chinese speakers. 

排除标准:

除发育性口吃外的其他言语、语言或沟通障碍、感觉障碍,以及其他的神经系统疾病;癫痫(或任何与非侵入性脑刺激技术有关的安全指标) 

Exclusion criteria:

Speech, language or communication disorders, sensory disorders, and other neurological disorders other than developmental stuttering; Epilepsy (or any safety indicators related to non-invasive brain stimulation techniques) 

研究实施时间:

Study execute time:

From2019-05-06To 2020-07-31 

干预措施:

Interventions:

组别:

Group 3

样本量:

30

Group:

Group 3

Sample size:

干预措施:

口吃常规治疗

干预措施代码:

Intervention:

Conventional treatment of stuttering

Intervention code:

组别:

Group 2

样本量:

10

Group:

Group 2

Sample size:

干预措施:

非侵入性脑刺激技术

干预措施代码:

Intervention:

non-invasive brain stimulation (NIBS)

Intervention code:

组别:

Group 3

样本量:

10

Group:

Group 3

Sample size:

干预措施:

非侵入性脑刺激技术假刺激

干预措施代码:

Intervention:

shamed non-invasive brain stimulation (NIBS)

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):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市妇女儿童医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou Women and Children's Medical Center  

Level of the institution:

Tertiary A Hosipital 

测量指标:

Outcomes:

指标中文名:

口吃严重程度分级

指标类型:

主要指标 

Outcome:

Stuttering Severity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

行为评定

指标类型:

主要指标 

Outcome:

Behavior Assessment Battery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

沟通态度

指标类型:

主要指标 

Outcome:

communication attitudes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑部核磁共振

指标类型:

主要指标 

Outcome:

MRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑电图

指标类型:

主要指标 

Outcome:

EEG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

智力

指标类型:

主要指标 

Outcome:

intelligence quotient

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

语言能力

指标类型:

主要指标 

Outcome:

Language ability

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 4 years
最大 Max age 16 years