视空间记忆任务中认知障碍老年人的眼动异常及其神经基础

注册号:

Registration number:

ChiCTR2500100790 

最近更新日期:

Date of Last Refreshed on:

2025-04-15 14:43:43 

注册时间:

Date of Registration:

2025-04-15 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

视空间记忆任务中认知障碍老年人的眼动异常及其神经基础

Public title:

Eye Movement Patterns and Neural Correlates in Cognitively Impaired Older Adults During Visuospatial Memory Tasks

注册题目简写:

English Acronym:

研究课题的正式科学名称:

视空间记忆任务中认知障碍老年人的眼动异常及其神经基础

Scientific title:

Eye Movement Patterns and Neural Correlates in Cognitively Impaired Older Adults During Visuospatial Memory Tasks

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:

汪沾 

研究负责人:

喻婧 

Applicant:

Zhan Wang 

Study leader:

Jing Yu 

申请注册联系人电话:

Applicant telephone:

+86 189 7491 9382

研究负责人电话:

Study leader's
telephone:

+86 136 1823 3832

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:

wangzhan98@email.swu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

helen12@swu.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:

中国重庆市北碚区天生路2号

研究负责人通讯地址:

中国重庆市北碚区天生路2号

Applicant address:

2 Tiansheng Road, Beibei District, Chongqing

Study leader's address:

2 Tiansheng Road, Beibei District, Chongqing

申请注册联系人邮政编码:

Applicant postcode:

521000

研究负责人邮政编码:

Study leader's postcode:

521000

申请人所在单位:

西南大学

Applicant's institution:

Southwest University

研究负责人所在单位:

西南大学

Affiliation of the Leader:

Southwest University

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:

H23187

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:

西南大学心理学部伦理委员会

Name of the ethic committee:

Institutional Review Board of Faculty of Psychology, Southwest University

伦理委员会批准日期:

Date of approved by ethic committee:

2023-10-18 00:00:00

伦理委员会联系人:

胡清清

Contact Name of the ethic committee:

Qingqing Hu

伦理委员会联系地址:

重庆市北碚区天生路2号西南大学心理学部

Contact Address of the ethic committee:

Department of Psychology, Southwest University, 2 Tiansheng Road, Beibei District, Chongqing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23 6825 2777

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:

西南大学

Primary sponsor:

Southwest University

研究实施负责(组长)单位地址:

重庆市北碚区天生路2号

Primary sponsor's address:

2 Tiansheng Road, Beibei District, Chongqing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

西南大学

具体地址:

重庆市北碚区天生路2号

Institution
hospital:

Southwest University

Address:

2 Tiansheng Road, Beibei District, Chongqing

经费或物资来源:

国家自然科学基金

Source(s) of funding:

The National Natural Science Foundation of China

研究疾病:

认知障碍  

Target disease:

Cognitive impairment

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:

病例对照研究 

Study design:

Case-Control study 

研究目的:

本研究拟通过基于眼动特征的视空间记忆范式考察眼动指标作为特征来区分正常老年人和MCI的准确性、敏感性和特异性。  

Objectives of Study:

In this study, we aim to examine the accuracy, sensitivity, and specificity of eye movement indicators as features to distinguish between normal older adults and MCI through a visuospatial memory paradigm based on eye movement features.

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:

Exclusion criteria:

None

研究实施时间:

Study execute time:

From 2023-10-15 00:00:00 To 2023-12-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-11-20 00:00:00 To 2023-11-24 00:00:00

干预措施:

Interventions:

组别:

正常老年人

样本量:

30

Group:

Healthy controls

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

认知障碍老年人

样本量:

30

Group:

Individuals with mild cognitive impairment

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):

重庆 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

西南大学 

单位级别:

大学 

Institution
hospital:

Southwest University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

再认正确性

指标类型:

主要指标

Outcome:

Recognition accuracy

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全局眼动模式

指标类型:

主要指标

Outcome:

Global eye movement

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:

NA

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 55 years
最大 Max age 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:

None

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

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):

2025.5.1在https://osf.io上公开原始数据

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

Raw data will be publicly available at https://osf.io on 2025.5.1.

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:

被试基本信息及认知情况通过发放纸质问卷采集,行为数据采集通过eprime采集,眼动数据通过eyelink采集;随后数据将会上传osf保存。

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

Basic demographic and cognitive information of the participants were collected through paper-based questionnaires, behavioral data were collected using E-Prime, and eye movement data were collected using EyeLink. The data will then be uploaded and stored on OSF.

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:

 2025-04-15 14:43:31