发展性阅读障碍的早期感知觉加工缺陷

注册号:

Registration number:

ChiCTR2600125043 

最近更新日期:

Date of Last Refreshed on:

2026-05-20 16:30:59 

注册时间:

Date of Registration:

2026-05-20 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

发展性阅读障碍的早期感知觉加工缺陷

Public title:

Early perceptual processing deficits in developmental dyslexia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

发展性阅读障碍的早期感知觉加工缺陷

Scientific title:

Early perceptual processing deficits in developmental dyslexia

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:

王久菊 

研究负责人:

王久菊 

Applicant:

Jiuju Wang 

Study leader:

Jiuju Wang 

申请注册联系人电话:

Applicant telephone:

+86 134 2632 9067

研究负责人电话:

Study leader's
telephone:

+86 134 2632 9067

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:

wangjiuju@bjmu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

wangjiuju@bjmu.edu.cn

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:

北京市海淀区花园北路51号

研究负责人通讯地址:

北京市海淀区花园北路51号

Applicant address:

No. 51, North Huayuan Road, Haidian District, Beijing

Study leader's address:

No. 51, North Huayuan Road, Haidian 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:

北京大学第六医院

Applicant's institution:

Peking University Sixth Hospital

研究负责人所在单位:

北京大学第六医院

Affiliation of the Leader:

Peking University Sixth Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

(2026)伦审第(21)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:

北京大学第六医院(精神卫生研究所)医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Peking University Sixth Hospital (Institute of Mental Health).

伦理委员会批准日期:

Date of approved by ethic committee:

2026-03-25 00:00:00

伦理委员会联系人:

王雪芹

Contact Name of the ethic committee:

Xueqin Wang

伦理委员会联系地址:

北京市海淀区花园北路51号

Contact Address of the ethic committee:

No. 51, North Huayuan Road, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 62723770

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:

北京大学第六医院

Primary sponsor:

Peking University Sixth Hospital

研究实施负责(组长)单位地址:

北京市海淀区花园北路51号

Primary sponsor's address:

No. 51, North Huayuan Road, Haidian District, Beijing

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):

北京大学第六医院

具体地址:

北京市海淀区花园北路51号

Institution
hospital:

Peking University Sixth Hospital

Address:

No. 51, North Huayuan Road, Haidian District, Beijing

经费或物资来源:

自筹

Source(s) of funding:

Self-financed

研究疾病:

阅读障碍  

Target disease:

dyslexia

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

从视听觉信息加工的早期阶段入手,系统揭示阅读障碍个体在早期感知觉加工环节的异常特征,阐明其对阅读加工的限制机制。  

Objectives of Study:

Starting from the early stage of audiovisual information processing, the abnormal characteristics of dyslexia individuals in the early perceptual processing process are systematically revealed, and their limiting mechanism for reading processing is clarified.

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.合并严重躯体疾病、脑器质性疾病及脑外伤史患者; 2.经MINI评估,排除其他精神疾病; 3.既往听力或视力器质性损伤; 4.伴有严重认知功能损伤或精神发育迟滞。

Exclusion criteria:

1.Patients with severe physical diseases, brain organic diseases and a history of brain trauma; 2.Other mental illnesses are excluded by MINI assessment; 3.Previous hearing or visual impairment; 4.Accompanied by severe cognitive impairment or mental retardation.

研究实施时间:

Study execute time:

From 2026-05-20 00:00:00 To 2029-01-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-05-20 00:00:00 To 2029-01-31 00:00:00

干预措施:

Interventions:

组别:

阅读障碍组

样本量:

60

Group:

Dyslexia group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

同年龄TD组

样本量:

60

Group:

Same age TD group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

同阅读水平TD组

样本量:

60

Group:

TD group with the same reading level

Sample size:

干预措施:

干预措施代码:

Intervention:

None

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):

北京大学第六医院 

单位级别:

三甲 

Institution
hospital:

Peking University Sixth Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

视觉诱发电位

指标类型:

主要指标

Outcome:

Visual evoked potential

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对比敏感度测试

指标类型:

次要指标

Outcome:

Contrast sensitivity test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉时序判断任务

指标类型:

次要指标

Outcome:

Visual temporal sequencing task

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

听觉诱发电位

指标类型:

主要指标

Outcome:

Auditory evoked potential

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

音调匹配任务

指标类型:

次要指标

Outcome:

Tone matching task

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

听觉时序判断任务

指标类型:

次要指标

Outcome:

Auditory temporal judgment task

Type:

Secondary 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

其它  

说明

Fate of sample:

0thers  

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 8 years
最大 Max age 13 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):

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

None

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):

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

None

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-05-20 16:30:50