ChiCTR2500109489 版本V1.1 版本创建时间2025/09/19 09:30:28 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500109489 

最近更新日期：

Date of Last Refreshed on：

 2025-09-19 09:28:07 

注册时间：

Date of Registration：

 2025-09-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

不同类型数学学习困难的认知神经机制及tDCS干预研究

Public title：

Cognitive Neural Mechanisms and Transcranial Direct Current Stimulation Intervention in Different Types of Mathematical Learning Difficulties

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同类型数学学习困难的认知神经机制及tDCS干预研究

Scientific title：

Cognitive Neural Mechanisms and Transcranial Direct Current Stimulation Intervention in Different Types of Mathematical Learning Difficulties

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：

夏丽婷 

研究负责人：

蔡丹 

Applicant：

Liting Xia 

Study leader：

Dan Cai 

申请注册联系人电话：

Applicant telephone：

 +86 159 8213 7989

研究负责人电话：

Study leader's
telephone：

+86 138 1792 2661

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：

 15982137989@163.com

研究负责人电子邮件：

Study leader's E-mail：

 caidan@shnu.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：

上海市徐汇区康健新村街道桂林路100号

研究负责人通讯地址：

上海市徐汇区康健新村街道桂林路100号

Applicant address：

No. 100, Guilin Road, Kangjian Xincun Sub-district, Xuhui District, Shanghai

Study leader's address：

No. 100, Guilin Road, Kangjian Xincun Sub-district, Xuhui District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

 200234

研究负责人邮政编码：

Study leader's postcode：

 200234

申请人所在单位：

上海师范大学心理学院

Applicant's institution：

Shanghai Normal University School of Psychology

研究负责人所在单位：

上海师范大学心理学院

Affiliation of the Leader：

Shanghai Normal University School of Psychology

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：

 上海师大伦理[2025]第064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：

上海师范大学学术伦理与道德委员会

Name of the ethic committee：

Academic Ethics and Moral Committee of Shanghai Normal University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-16 00:00:00

伦理委员会联系人：

刘作翔

Contact Name of the ethic committee：

Zuoxiang Liu

伦理委员会联系地址：

上海市徐汇区康健新村街道桂林路100号

Contact Address of the ethic committee：

No. 100, Guilin Road, Kangjian Xincun Sub-district, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 137 1879 7637

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 liuzuoxiang@shnu.edu.cn

研究实施负责（组长）单位：

上海师范大学心理学院

Primary sponsor：

Shanghai Normal University School of Psychology

研究实施负责（组长）单位地址：

上海市徐汇区康健新村街道桂林路100号

Primary sponsor's address：

No. 100, Guilin Road, Kangjian Xincun Sub-district, Xuhui 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)：

上海师范大学

具体地址：

上海市徐汇区康健新村街道桂林路100号

Institution
hospital：

Shanghai Normal University

Address：

No. 100, Guilin Road, Kangjian Xincun Sub-district, Xuhui District, Shanghai

经费或物资来源：

国家自然科学基金面上项目

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

数学困难  

Target disease：

Mathematical Learning Difficulties

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：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

(1) 明确数学困难(Mathematical Learning Difficulties, MLD) 的核心认知缺陷以及不同亚类型，揭示认知加工(缺陷)特征对各类 MLD 儿童的作用机制，提出 MLD 分类评估整合模型。基于三重编码模型以及数学困难的认知加工模型，并根据认知诊断模型(cognitive diagnostic models, CDMs )分析结果探讨不同类型 MLD 儿童的领域特殊性数学认知能力(如视觉- 空间、言语、近似数量系统等)和领域一般性认知能力(如抑制控制、工作记忆等)在不同层级数学任务(计算与问题解决等)表现上的贡献，最终获得解释 MLD 儿童认知机制的整合模型。 (2)揭示不同类型数学学习困难的认知加工(缺陷)特征及其作用机制的神经基础。利用 fNIRS 技术考察不同类型数学学习困难儿童 HIPS、AG、PSPL、PFC 脑区的神经激活状态， 确定不同类型数学学习困难儿童数学认知的特异性神经激活模式，为数学学习困难儿童核心认知缺陷特征提供脑神经方面的证据，为数学学习困难儿童认知机制的整合模型提供神经基础证据。 (3)描绘不同类型 MLD 儿童数学认知及脑功能发展轨迹。通过对三个年级小学生进行横断研究及持续一年的纵向追踪研究，探究 MLD 儿童数学认知发展的行为表现和脑功能发育特征，以刻画 DD 儿童认知与数学的行为表现及脑功能发展轨迹。 (4)识别和比较不同类型 MLD 学生对特定脑区经颅直流电刺激(tDCS)作用的方案、 反应的差异，包括脑区、频率和持续时间对学习效果的影响，确定最优的神经调控方案。 (5)评估特定神经调控方案对不同类型 MLD 学生的即时效果、长期效果以及迁移效果。 在采用 tDCS 干预后、间隔 6 个月及 12 个月，再次考察对不同类型 MLD 学生认知能力和数学能力，采用近红外光谱技术相应脑机制。考察 tDCS 作用于不同类型 MLD 儿童的效果，对领域一般性和特异性认知能力的迁移效果。  

Objectives of Study：

(1) To identify the core cognitive deficits and subtypes of Mathematical Learning Difficulties (MLD), to reveal the mechanism of cognitive processing characteristics on children with various types of MLD, and to propose an integrated model for the classification and assessment of MLD. Based on the triple coding model and the cognitive processing model of mathematical difficulties, and according to the results of cognitive diagnostic models (CDMs), the domain-specific mathematical cognitive abilities (e.g., visuospatial, verbal, and proximal quantitative system, etc.) and domain-general cognitive abilities (e.g., inhibitory control, and working memory, etc.) in different types of MLD children at different levels of the assessment were explored. (e.g., inhibitory control, working memory, etc.) in different levels of mathematical tasks (computation and problem solving, etc.), and ultimately obtain an integrated model to explain the cognitive mechanisms of children with MLD. (2) To reveal the neural basis of the cognitive processing deficits in different types of mathematical learning difficulties and their mechanisms of action. Using fNIRS technology, we will examine the neural activation status of HIPS, AG, PSPL, and PFC brain regions in children with different types of MLD, determine the specific neural activation patterns of math cognition in children with different types of MLD, provide brain and neural evidence for the core cognitive deficits in children with MLD, and provide neural basis for the integrated model of cognitive mechanisms in children with MLD. Evidence. (3) To depict the developmental trajectories of math cognition and brain function in children with different types of MLD. Through a cross-sectional study of three grades of elementary school students and a longitudinal tracking study lasting one year, we will explore the behavioral performance and brain function developmental characteristics of MLD children's mathematical cognitive development, in order to portray the behavioral performance and brain function developmental trajectories of cognitive and mathematical development of children with DD. (4) Identify and compare the differences in the protocols and responses of different types of MLD students to transcranial direct current stimulation (tDCS) in specific brain regions, including the effects of brain regions, frequency and duration on learning outcomes, and determine the optimal neuromodulation protocol. (5) Evaluate the immediate, long-term and migratory effects of specific neuromodulation programs on students with different types of MLD. After the tDCS intervention, at intervals of 6 and 12 months, the cognitive and mathematical abilities of students with different types of MLD were examined again, and the corresponding brain mechanisms were investigated by using near-infrared spectroscopy. The effects of tDCS on children with different types of MLD were examined, as were the effects on the transfer of domain-general and domain-specific cognitive abilities.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

7-12岁数学困难儿童和成绩位于正常范围内的儿童。

Inclusion criteria

Children aged 7-12 with mathematical difficulties and children whose academic performance is within the normal range.

排除标准：

学习动机低；曾有精神疾病病史或家族史；曾有脑创伤、神经系统疾病病史（如癫痫或脑卒中）；曾有头部手术；曾有意识丧失30 分钟以上；正服用精神类药物；近期头部有金属；近期头皮破损或炎症；确诊注意缺陷/多动障碍症或其他情绪障碍。

Exclusion criteria：

Low learning motivation; There is a history of mental illness or a family history of it. Has a history of brain trauma or neurological diseases (such as epilepsy or stroke); There was once a head surgery; Has lost consciousness for more than 30 minutes; Currently taking psychotropic drugs; There has been metal on the head recently. Recent scalp damage or inflammation; Diagnose attention deficit/hyperactivity disorder or other mood disorders.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-20 00:00:00 至 To 2028-09-20 00:00:00

干预措施：

Interventions：

组别：

数量表征困难组

样本量：

 20

Group：

Symbolic Quantitative Difficulty Subtype

Sample size：

干预措施：

分两个阶段进行。在第一阶段，由实验主试为其佩戴功能性近红外光谱成像(fNIRS) 设备，并进行必要的信号调试。之后，参与者被要求完成三重认知编码任务，评估其数量表征、 言语和视觉空间表征能力。fNIRS 设备将监测包括前额叶、顶内沟、角回及后顶叶小叶在内的 40 个通道的脑活动变化。任务前，主试提供详细指导并引导参与者进行练习，以熟悉实验流 程。 第二阶段在第一阶段任务完成后开始，需为参与者佩戴 tDCS 设备。招募儿童参与者各自完成 12 次 tDCS 干预，每次干预之间设定 72 小时的恢复期。符号数量表征困难亚型，电极位置定位于顶内沟。干预组接受1mA 直流电刺激 20 分钟，其中电流在起始和结束的 30 秒内逐渐增减。tDCS 刺激后，参与者在不再佩戴 tDCS 设备的情况下，重复进行第一阶段的任务，以评估刺激后认知能力的变化。

干预措施代码：

Intervention：

This was carried out in two phases. In the first phase, a functional near-infrared spectroscopy (fNIRS) device will be worn by the experimental subject and the necessary signal conditioning will be performed. Participants were then asked to complete a triple cognitive encoding task to assess their quantitative, verbal and visuospatial representations. fNIRS equipment monitored changes in brain activity in 40 channels including the prefrontal, intraparietal sulcus, angular gyrus and posterior parietal lobule. Prior to the task, participants were provided with detailed instructions and guided through a practice session to familiarize them with the experimental procedure. The second phase began after the completion of the first phase of the task and required the participant to wear the tDCS device. The electrodes were positioned in the intraparietal sulcus for the subtype of "Symbolic Quantitative Difficulty Subtype". The intervention group received 1mA tDCS for 20 minutes, in which the current was gradually increased and decreased over 30 seconds at the beginning and end. tDCS stimulation was followed by a repetition of the Phase 1 task with participants no longer wearing the tDCS device to assess post-stimulation changes in cognitive performance. Participants each completed 12 tDCS interventions, with a 72-hour recovery period set between each intervention.

Intervention code：

组别：

言语表征困难组

样本量：

 20

Group：

Linguistic Difficulty Subtype

Sample size：

干预措施：

分两个阶段进行。在第一阶段，由实验主试为其佩戴功能性近红外光谱成像(fNIRS) 设备，并进行必要的信号调试。之后，参与者被要求完成三重认知编码任务，评估其数量表征、 言语和视觉空间表征能力。fNIRS 设备将监测包括前额叶、顶内沟、角回及后顶叶小叶在内的 40 个通道的脑活动变化。任务前，主试提供详细指导并引导参与者进行练习，以熟悉实验流 程。第二阶段在第一阶段任务完成后开始，需为参与者佩戴 tDCS 设备。言语表征困难亚型，电极位置定位于角回。干预组接受1mA 直流电刺激 20 分钟，其中电流在起始和结束的 30 秒内逐渐增减。tDCS 刺激后，参与者在不再佩戴 tDCS 设备的情况下，重复进行第一阶段的任务，以评估刺激后认知能力的变化。参与者各自完成 12 次 tDCS 干预，每次干预之间设定 72 小时的恢复期。

干预措施代码：

Intervention：

It was conducted in two phases. In the first phase, a functional near-infrared spectroscopic imaging (fNIRS) device was worn by the experimental master subject and the necessary signal conditioning was performed. Participants were then asked to complete a triple cognitive coding task to assess their quantitative, verbal, and visuospatial representations. fNIRS equipment monitored changes in brain activity in 40 channels, including the prefrontal, intraparietal sulcus, angular gyrus, and posterior parietal lobule. Prior to the task, participants were provided with detailed instructions and guided through a practice session to familiarize them with the experimental procedure. The second phase began after the completion of the first phase of the task and required the participant to wear the tDCS device. The electrodes were positioned in the angular gyrus for the Linguistic difficulty subtype. The intervention group received 1 mA tDCS for 20 minutes, with the current gradually increasing and decreasing over a 30-second period at the beginning and end of the stimulation. tDCS stimulation was followed by a repetition of the Phase 1 task without the tDCS device to assess post-stimulation cognitive changes. Participants each completed 12 tDCS interventions, with a 72-hour recovery period set between each intervention.

Intervention code：

组别：

视觉空间表征困难组

样本量：

 20

Group：

Visual-spatial Attention Difficulty Subtype

Sample size：

干预措施：

分两个阶段进行。在第一阶段，由实验主试为其佩戴功能性近红外光谱成像(fNIRS) 设备，并进行必要的信号调试。之后，参与者被要求完成三重认知编码任务，评估其数量表征、 言语和视觉空间表征能力。fNIRS 设备将监测包括前额叶、顶内沟、角回及后顶叶小叶在内的 40 个通道的脑活动变化。任务前，主试提供详细指导并引导参与者进行练习，以熟悉实验流 程。第二阶段在第一阶段任务完成后开始，需为参与者佩戴 tDCS 设备。视觉空间表征困难亚型，电极位置定位于后顶叶。干预组接受1mA 直流电刺激 20 分钟，其中电流在起始和结束的 30 秒内逐渐增减。tDCS 刺激后，参与者在不再佩戴 tDCS 设备的情况下，重复进行第一阶段的任务，以评估刺激后认知能力的变化。参与者各自完成 12 次 tDCS 干预，每次干预之间设定 72 小时的恢复期。

干预措施代码：

Intervention：

This was done in two phases. In the first phase, a functional near-infrared spectroscopic imaging (fNIRS) device was worn by the experimental master subject and the necessary signal conditioning was performed. Participants were then asked to complete a triple cognitive coding task to assess their quantitative, verbal, and visuospatial representations. fNIRS equipment will monitor changes in brain activity in 40 channels including the prefrontal, intraparietal sulcus, angular gyrus, and posterior parietal lobule. Prior to the task, participants were provided with detailed instructions and guided through a practice session to familiarize them with the experimental procedure. The second phase began after the completion of the first phase of the task, and participants were required to wear the tDCS device. The visual-spatial attention difficulty subtype was performed, and the electrodes were positioned in the posterior parietal lobe. The intervention group received 1 mA tDCS for 20 minutes, with the current gradually increasing and decreasing over a 30-second period at the beginning and end of the session. tDCS stimulation was followed by a repetition of the phase 1 task without the tDCS device to assess post-stimulation cognitive changes. Participants each completed 12 tDCS interventions, with a 72-hour recovery period set between each intervention.

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control Group

Sample size：

干预措施：

分两个阶段进行。在第一阶段，由实验主试为其佩戴功能性近红外光谱成像(fNIRS) 设备，并进行必要的信号调试。之后，参与者被要求完成三重认知编码任务，评估其数量表征、 言语和视觉空间表征能力。fNIRS 设备将监测包括前额叶、顶内沟、角回及后顶叶小叶在内的 40 个通道的脑活动变化。任务前，主试提供详细指导并引导参与者进行练习，以熟悉实验流 程。第二阶段在第一阶段任务完成后开始，需为参与者佩戴 tDCS 设备。安慰剂组接受 20 分钟假刺激。tDCS假刺激后，参与者在不再佩戴 tDCS 设备的情况下，重复进行第一阶段的任务，以评估刺激后认知能力的变化。 参与者各自完成 12 次 tDCS 假刺激干预，每次干预之间间隔72 小时。

干预措施代码：

Intervention：

It was conducted in two phases. In the first phase, a functional near-infrared spectroscopic imaging (fNIRS) device was worn by the experimental master subject and the necessary signal conditioning was performed. Participants were then asked to complete a triple cognitive coding task to assess their quantitative, verbal, and visuospatial representations. fNIRS equipment will monitor changes in brain activity in 40 channels including the prefrontal, intraparietal sulcus, angular gyrus, and posterior parietal lobule. Prior to the task, participants were provided with detailed instructions and guided through a practice session to familiarize them with the experimental procedure. The second phase began after the completion of the first phase of the task, and participants were required to wear the tDCS device. The placebo group received a 20-minute sham stimulation. tDCS sham stimulation was followed by a repeat of the Phase 1 task without the tDCS device to assess post-stimulation cognitive changes. Participants each completed 12 tDCS sham stimulation interventions with 72 hours between each intervention.

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)：

 上海市精神卫生中心 

单位级别：

 三甲 

Institution
hospital：

Shanghai Mental Health Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

点估计任务

指标类型：

主要指标

Outcome：

Dot estimation task

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

数字线估计任务

指标类型：

主要指标

Outcome：

Number line estimation task

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

阅读流畅性测验

指标类型：

主要指标

Outcome：

Reading fluency test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮博迪图片词汇测验(PPVT-R)

指标类型：

主要指标

Outcome：

Peabody Picture Vocabulary Test,PPVT

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

空间 N-back 任务

指标类型：

主要指标

Outcome：

Spatial N‐back task

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

积木任务

指标类型：

主要指标

Outcome：

Toy building blocks

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

颜色斯特鲁普测试

指标类型：

次要指标

Outcome：

Color stroop

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

非言语矩阵测验

指标类型：

次要指标

Outcome：

Nonverbal matrices 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：

数字正背

指标类型：

次要指标

Outcome：

Forward Digit Span

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

数字倒背

指标类型：

次要指标

Outcome：

Reverse/Backwards Digit Span

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

计算流畅性

指标类型：

主要指标

Outcome：

Math fluency

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

数学运算

指标类型：

主要指标

Outcome：

Numerical calculation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

数学问题解决

指标类型：

主要指标

Outcome：

Math problem‐solving

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：

无

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 7 岁 years
最大 Max age 12 岁 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）：

通过计算机随机数模块生成分组序列，按1:1比例分配至实验组（真实tDCS）与对照组（伪刺激）。

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

Sequences of groups were generated by a computerized random number module and assigned to the experimental group (real tDCS) versus the control group (sham stimulation) in a 1:1 ratio.

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：

本研究采用单盲实验设计。对照组被试将接受伪刺激(sham tDCS):电极放置位置与实验组相同,设备会模拟真实刺激的初始触感(如短暂轻微刺痛或瘙痒),但在20分钟内不输出有效电流。此方法已通过既往研究验证,能有效维持被试对分组状态的盲性,同时确保实验安全性。操作全程由经过培训的主试严格执行,且实验结束后将进行盲法效果检验(如询问被试猜测的分组情况)。

Blinding：

This study utilizes a single-blind experimental design. Control subjects will receive sham tDCS: the electrodes will be placed in the same position as in the experimental group, and the device will simulate the initial sensation of real stimulation (e.g., transient mild tingling or itching), but will not deliver an effective current for 20 minutes. This method has been validated in previous studies to maintain blinding to the group state while ensuring experimental safety. The procedure was performed by a trained subject, and the blinding effect (e.g., asking subjects about their guessed grouping status) will be tested at the end of the experiment.

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）：

无

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：

CRF;EDC

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

CRF;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：

  2025-09-19 09:28:01