风险决策视角下“描述”与“体验”的行为规律——基于脑损伤病人的实验研究

注册号:

Registration number:

ChiCTR2500105229 

最近更新日期:

Date of Last Refreshed on:

2025-07-01 09:03:08 

注册时间:

Date of Registration:

2025-07-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

风险决策视角下“描述”与“体验”的行为规律——基于脑损伤病人的实验研究

Public title:

The behavioral patterns of "description" and "experience" from the perspective of risk decision-making: An experimental study based on patients with brain injuries

注册题目简写:

English Acronym:

研究课题的正式科学名称:

风险决策视角下“描述”与“体验”的行为规律——基于脑损伤病人的实验研究

Scientific title:

The behavioral patterns of "description" and "experience" from the perspective of risk decision-making: An experimental study based on patients with brain injuries

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:

刘玲玉 

研究负责人:

刘玲玉 

Applicant:

Lingyu Liu 

Study leader:

Lingyu Liu 

申请注册联系人电话:

Applicant telephone:

+86 15601865495

研究负责人电话:

Study leader's
telephone:

+86 21 37730011

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:

Happyneurologist@163.com

研究负责人电子邮件:

Study leader's E-mail:

Happyneurologist@163.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:

上海市松江区光星路2209号

研究负责人通讯地址:

上海市松江区光星路2209号

Applicant address:

No. 2209, Guangxing Road, Songjiang District, Shanghai

Study leader's address:

No. 2209, Guangxing Road, Songjiang District, Shanghai

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:

上海市养志康复医院(上海市阳光康复中心)

Applicant's institution:

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Hospital)

研究负责人所在单位:

上海市养志康复医院(上海市阳光康复中心)

Affiliation of the Leader:

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation 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:

养志伦审字〔2025〕032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:

上海市养志康复医院(上海市阳光康复中心)医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital Shanghai Sunshine Rehabilitation Center

伦理委员会批准日期:

Date of approved by ethic committee:

2025-06-04 00:00:00

伦理委员会联系人:

王涛

Contact Name of the ethic committee:

Wang Tao

伦理委员会联系地址:

上海市松江区光星路2209号

Contact Address of the ethic committee:

No. 2209, Guangxing Road, Songjiang District, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 37730011

伦理委员会联系人邮箱:

Contact email of the ethic committee:

13644870352@163.com

研究实施负责(组长)单位:

上海市养志康复医院

Primary sponsor:

Shanghai Yangzhi rehabilitation hospital

研究实施负责(组长)单位地址:

上海市松江区光星路2209号

Primary sponsor's address:

No. 2209, Guangxing Road, Songjiang District, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市养志康复医院(上海市阳光康复中心)

具体地址:

上海市松江区光星路2209号

Institution
hospital:

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Hospital)

Address:

No. 2209, Guangxing Road, Songjiang District, Shanghai

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

脑损伤  

Target disease:

Brain injuries

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:

以内侧前额叶(MPFC)、基底节(BG)和脑岛(insula)损伤的患者为主要研究对象,探讨其在“描述性”与“体验性”两类风险决策情境中,在风险敏感性、奖赏学习和反馈加工等多个认知维度上,相较于正常对照人群是否存在高级认知功能的缺陷,从而为脑损伤患者的认知能力评估与预后判断提供理论依据与实践参考。  

Objectives of Study:

This study mainly focuses on patients with lesions in the medial prefrontal cortex (MPFC), basal ganglia (BG), and insula. It explores whether there are deficits in advanced cognitive functions in multiple cognitive dimensions such as risk sensitivity, reward learning, and feedback processing compared to normal control groups in two types of risk decision-making contexts: "descriptive" and "experiential". This aims to provide theoretical basis and practical references for the assessment of cognitive abilities and prognosis judgment of brain-injured patients.

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.无法理解任务要求的被试;
2.有精神疾病的被试或长期服用精神药物者;
3.基底节受累累及丘脑的被试;
4.正在参加影响本研究结果的其它研究试验者;

Exclusion criteria:

1.Participants who were unable to understand the task requirements;
2.Participants with mental disorders or those who have been taking mental medications for a long time;
3.Subjects with basal ganglia lesions and those with thalamic lesions;
4.Participants in other research trials that are influencing the results of this study;

研究实施时间:

Study execute time:

From 2025-06-01 00:00:00 To 2027-05-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-07-15 00:00:00 To 2027-05-31 00:00:00

干预措施:

Interventions:

组别:

健康对照组

样本量:

40

Group:

Healthy control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

脑损伤试验组

样本量:

30

Group:

Brain injury experimental group

Sample size:

干预措施:

脑损伤

干预措施代码:

Intervention:

Brain injury

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市养志康复医院(上海市阳光康复中心) 

单位级别:

三级 

Institution
hospital:

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Hospital)

Level of the institution:

Tertiary

测量指标:

Outcomes:

指标中文名:

风险偏好参数

指标类型:

主要指标

Outcome:

Risk Preference Parameters

Type:

Primary indicator

测量时间点:

观察结束

测量方法:

通过前景理论模型拟合

Measure time point of outcome:

end of trial

Measure method:

By fitting the prospect theory model

指标中文名:

风险选择比例

指标类型:

主要指标

Outcome:

Proportion of Risky Choices

Type:

Primary indicator

测量时间点:

观察结束

测量方法:

在不同场景(收益、损失、混合)及不同期望值水平下,被试选择风险性选项的百分比

Measure time point of outcome:

end of trial

Measure method:

In different scenarios (gain, loss, mixed) and at different levels of expected value, the percentage of participants who chose risky options

指标中文名:

学习准确率曲线

指标类型:

主要指标

Outcome:

Choice Accuracy

Type:

Primary indicator

测量时间点:

观察结束

测量方法:

个体在选择“最优”选项(即具有更高预设回报概率的选项)的准确率

Measure time point of outcome:

end of trial

Measure method:

The accuracy rate of individuals in choosing the "optimal" option (that is, the option with a higher preset probability of return)

指标中文名:

学习率

指标类型:

主要指标

Outcome:

Learning Rate

Type:

Primary indicator

测量时间点:

观察结束

测量方法:

反映个体根据新获得的奖赏/惩罚信息更新其对选项价值估计的速度

Measure time point of outcome:

end of trial

Measure method:

Reflects the speed at which an individual updates their estimation of the value of options based on newly acquired reward/punishment information.

指标中文名:

描述性风险决策任务

指标类型:

次要指标

Outcome:

Descriptive risk decision 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:

Q 值/主观期望价值

指标类型:

次要指标

Outcome:

Q-values / Subjective Expected Values

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

赢则留-输则转策略比例

指标类型:

次要指标

Outcome:

Win-Stay, Lose-Shift Strategy Proportion

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:

N/A

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 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:

不公开/Private

盲法:

Blinding:

None

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:

病例记录表

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

Case Record Form,CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2025-07-01 09:03:00