ChiCTR2600120244 版本V1.0 版本创建时间2026/03/11 10:50:59 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：

 ChiCTR2600120244 

最近更新日期：

Date of Last Refreshed on：

 2026-03-11 10:50:06 

注册时间：

Date of Registration：

 2026-03-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

SLE患者心理、行为与磁共振脑功能变化的研究

Public title：

Study on Psychological, Behavioral, and Magnetic Resonance Brain Functional Changes in SLE Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

SLE患者心理、行为与磁共振脑功能变化的研究

Scientific title：

Study on Psychological, Behavioral, and Magnetic Resonance Brain Functional Changes in SLE Patients

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：

白茹 

研究负责人：

白茹 

Applicant：

Bai Ru 

Study leader：

Bai Ru 

申请注册联系人电话：

Applicant telephone：

 +86 159 6948 7715

研究负责人电话：

Study leader's
telephone：

+86 871 65324888

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：

 76266814@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 76266814@qq.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：

云南省昆明市五华区西昌路295号

研究负责人通讯地址：

云南省昆明市五华区西昌路295号

Applicant address：

No. 295, Xichang Road, Wuhua District, Kunming City,Yunnan

Study leader's address：

No. 295, Xichang Road, Wuhua District, Kunming City,Yunnan

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：

昆明医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Kunming Medical University

研究负责人所在单位：

昆明医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Kunming Medical University

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：

 （2025）伦审L第406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：

昆明医科大学第一附属医院伦理委员会

Name of the ethic committee：

Medical Ethics committee of The First Affiliated Hospital of Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-19 00:00:00

伦理委员会联系人：

王婷

Contact Name of the ethic committee：

Wang Ting

伦理委员会联系地址：

云南省昆明市五华区西昌路295号

Contact Address of the ethic committee：

No. 295, Xichang Road, Wuhua District, Kunming City,Yunnan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 871 65328584

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 KYFYYEC@163.com

研究实施负责（组长）单位：

昆明医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

云南省昆明市五华区西昌路295号

Primary sponsor's address：

No. 295, Xichang Road, Wuhua District, Kunming City,Yunnan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南省

市(区县)：

Country：

China

Province：

Yunnan

City：

单位(医院)：

昆明医科大学第一附属医院

具体地址：

云南省昆明市五华区西昌路295号

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Address：

No. 295, Xichang Road, Wuhua District, Kunming City,Yunnan

经费或物资来源：

省级临床医学中心科研项目

Source(s) of funding：

Department/Directorate Level

研究疾病：

系统性红斑狼疮  

Target disease：

Systemic lupus erythematosus

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：

收集60例SLE患者，以及性别、年龄、受教育年限匹配的健康对照组进行sMRI、fMRI和DTI扫描，进行相关量表的评定。通过相应的预处理软件，全面分析灰白质体积、密度、皮层厚度，局部一致性（ReHo）、低频振幅（ALFF）和白质各项异性分数（FA）、平均扩散系数（MD）等脑结构和功能指标，比较两组以上各指标中存在的异常，了解SLE患者脑损害的特点。 分别利用sMRI、DTI和fMRI数据构建SLE患者的脑功能网络，从小世界网络的全局属性和局部属性特征以及rich-club网络等角度出发，探索SLE患者脑网络改变及脑功能变化的发病机制。 采用基于VBM方法预处理得到的灰质体积、白质体积特征，SBM方法得到的皮质厚度特征，TBSS方法预处理得到的FA值和MD值，fMRI预处理得到的ReHo值和ALFF值进行SLE多指标机器学习研究，通过机器学习提取出属于SLE脑网络特征及表型特征。 收集患者的临床特征，检测SLE密切相关的自身抗体（包括与神经系统损害相关的自身抗体）、细胞因子、淋巴亚群绝对计数分析，讨论临床特征与神经系统密切相关的自身抗体、细胞因子、淋巴亚群绝对计数分析与以上脑损伤的关系，分析MRI指标结合自身抗体、细胞因子、淋巴亚群绝对计数分析的检测、量表的评定用于SLE探讨脑功能变化的发病机制。  

Objectives of Study：

A total of 60 SLE patients were recruited, along with healthy controls matched for gender, age, and years of education, to undergo structural MRI (sMRI), functional MRI (fMRI), and diffusion tensor imaging (DTI) scanning, with relevant scales administered for assessment. Through appropriate preprocessing software, comprehensive analyses were conducted on gray and white matter volume, density, cortical thickness, regional homogeneity (ReHo), amplitude of low-frequency fluctuations (ALFF), fractional anisotropy (FA), and mean diffusivity (MD) as brain structural and functional indicators. Comparisons between the two groups were performed to identify abnormalities in these metrics and to characterize the features of brain damage in SLE patients. Brain functional networks were constructed for SLE patients utilizing sMRI, DTI, and fMRI data separately. From the perspectives of global and local properties of small-world networks, as well as rich-club organization, the study explored alterations in brain networks and the pathogenesis of functional brain changes in SLE.Machine learning approaches were employed using gray matter volume and white matter volume features obtained from voxel-based morphometry (VBM) preprocessing, cortical thickness features from surface-based morphometry (SBM), FA and MD values from tract-based spatial statistics (TBSS) preprocessing, and ReHo and ALFF values from fMRI preprocessing to conduct multi-modal imaging studies in SLE.The brain network features and phenotypic features of SLE were extracted by machine learning. The clinical characteristics of the patients were collected, and the autoantibodies (including autoantibodies related to nervous system damage), cytokines, and absolute counts of lymphoid subsets closely related to SLE were detected. The relationship between the absolute counts of autoantibodies, cytokines, and lymphoid subsets closely related to clinical characteristics and nervous system and the above brain injury was discussed. The MRI indexes combined with the detection of autoantibodies, cytokines, and absolute counts of lymphoid subsets and the evaluation of the scale were analyzed to explore the pathogenesis of brain function changes in SLE.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1、符合美国风湿病学会（ACR）1997年推荐的系统性红斑狼疮（SLE）的分类标准或2009年ACR对SLE分类标准； 2、年龄18-50岁； 3、小学或以上文化程度，知晓汉语并能理解量表内容，完成量表者； 4、患者本人及监护人签署知情同意书。 对照组： 1.年龄、性别与患者匹配； 2.自愿参加本研究； 3.年龄 18-50 岁； 4.小学及小学以上文化

Inclusion criteria

1.Meeting the 1997 classification criteria for systemic lupus erythematosus (SLE) recommended by the American College of Rheumatology (ACR) or the 2009 ACR classification criteria for SLE; 2.Aged 18–50 years; 3.Educational level of primary school or above, proficient in Mandarin Chinese with capacity to comprehend scale contents, and capable of completing the questionnaires; 4.Signed informed consent by the patient and their guardian. Control group: 1. Age and gender matched with patients; 2. Voluntarily participate in this study; 3. Age 18-50 years; 4. Elementary school education or above

排除标准：

1、诊断精神分裂症、精神发育迟滞、酒滥用、酒依赖或者其他精神活性物质依赖者； 2、有过重大脑器质性疾病史，包括外伤、肿瘤、中风、感染、传染、癫痫、明确脑变性疾病；合并其他免疫病，符合ACR类风湿关节炎、系统性硬化、干燥综合征（原发或继发）其他结缔组织病、药物诱发SLE； 3、严重心、肝、肾、肺功能不全患者； 4、女性在怀孕、哺乳期；或准备怀孕者； 5、有磁共振禁忌症者，如植入血管支架、起搏器、金属假牙、助听器等；有幽闭恐惧症等。 6、既往有可能引起大脑萎缩的临床情况者（中风、高血压、糖尿病、药物或酒依赖）； 对照组： 1.有既往或现在的明显躯体疾病家族及现病史； 2.有免疫系统疾病家族及现病史； 3.有神经精神疾病家族及现病史； 4.物质滥用史，并由一位经验丰富的精神科医师使用 DSM-IV 的结构化临床访谈非患者版本进行筛选。

Exclusion criteria：

1.Diagnosed with schizophrenia, mental retardation, alcohol abuse, alcohol dependence, or other psychoactive substance dependence; 2.History of major organic brain diseases, including trauma, tumor, stroke, infection, contagious disease, epilepsy, or definite neurodegenerative disorders; comorbid with other autoimmune diseases meeting ACR classification criteria for rheumatoid arthritis, systemic sclerosis, Sj?gren's syndrome (primary or secondary), other connective tissue diseases, or drug-induced SLE; 3.Patients with severe cardiac, hepatic, renal, or pulmonary insufficiency; 4.Women who are pregnant, lactating, or planning pregnancy; 5.Patients with MRI contraindications, such as implanted vascular stents, pacemakers, metal dentures, hearing aids, etc.; or patients with claustrophobia; 6.Patients with previous clinical conditions potentially causing brain atrophy (stroke, hypertension, diabetes mellitus, drug or alcohol dependence). Control Group: 1. Individuals with a family or personal history of significant somatic diseases; 2. Individuals with a family or personal history of immune system disorders; 3. Individuals with a family or personal history of neuropsychiatric disorders; 4. Individuals with a history of substance abuse, screened by an experienced psychiatrist using the DSM-IV Structured Clinical Interview for Non-Patient Version.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2028-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-27 00:00:00 至 To 2028-07-01 00:00:00

干预措施：

Interventions：

组别：

系统性红斑狼疮组

样本量：

 60

Group：

Systemic Lupus Erythematosus Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

健康对照组

样本量：

 60

Group：

Healthy Control Group

Sample size：

干预措施：

无

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)：

 云南省 

市(区县)：

  

Country：

China

Province：

Yunnan

City：

单位(医院)：

 昆明医科大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

First Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

自评量表评分：症状自评量表SCL-90、焦虑自评量表SAS、抑郁自评量表SDS、健康生活质量量表SF-36、疲劳严重度量表FSS；

指标类型：

主要指标

Outcome：

Self-report scales scores: Symptom Checklist-90, Self-Rating Anxiety Scale, Self-Rating Depression Scale , 36-Item Short Form Health Survey, Fatigue Severity Scale;

Type：

Primary indicator

测量时间点：

第0周

测量方法：

自评量表：症状自评量表、焦虑、抑郁自评量表、健康生活质量量表、疲劳严重度量表，他评量表：汉密尔顿焦虑量表、汉密尔顿抑郁量表、蒙特利尔认知评估量表；

Measure time point of outcome：

0 weeks

Measure method：

Self-report scales: Symptom Checklist-90, Self-Rating Anxiety Scale, Self-Rating Depression Scale, 36-Item Short Form Health Survey, Fatigue Severity Scale; Clinician-administered scales: Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, Montreal Cognitive Assessment.

指标中文名：

sMRI、fMRI和DTI数据；SLE密切相关的自身抗体、细胞因子、淋巴亚群绝对计数分析

指标类型：

主要指标

Outcome：

sMRI, fMRI, and DTI data; SLE-related autoantibodies, cytokines, and absolute lymphocyte subset count analysis.

Type：

Primary indicator

测量时间点：

第0周

测量方法：

在量表评估当天早上 8 点前采集参与者空腹血 10ml，静置 30min-1h 后， 以 3000r/min 离心 15min，分离出血清，置于-80℃冰箱冻存，检测神经系统损害相关的自身抗体。GE750机器采集sMRI, fMRI, and DTI 数据；

Measure time point of outcome：

0 weeks

Measure method：

Fasting blood samples (10 mL) were collected from participants before 8:00 AM on the day of scale assessment. After standing for 30 minutes to 1 hour, the samples were centrifuged at 3,000 rpm for 15 minutes to separate serum, which was then stored at -80°C for subsequent detection of autoantibodies related to neurological damage. sMRI, fMRI, and DTI data were acquired using a GE 750 scanner.

指标中文名：

他评量表评分：汉密尔顿焦虑量表HAMA、汉密尔顿抑郁量表HAMD、蒙特利尔认知评估量表MoCA；

指标类型：

主要指标

Outcome：

Clinician-administered scale scores : Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale,Montreal Cognitive Assessment;

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：

外周静脉血

组织：

Sample Name：

Peripheral venous blood

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 18 岁 years
最大 Max age 50 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）：

无

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：

无

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）：

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：

1.病例报告表（CRF）制定：根据研究方案制定 CRF，以 CRF 收集受试者相关信息； 2.电子数据库构建：构建电子数据库，完成纸质 CRF 后及时、准确录入电子数据库。必要时可以再次对遗漏或模糊信息进行补充询问。

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

Case Report Form (CRF) Development: CRFs were developed according to the study protocol to collect relevant information from subjects;Electronic Database Construction: An electronic database was constructed, and data from paper CRFs were entered promptly and accurately. Supplementary inquiries for missing or ambiguous information were conducted when necessary.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-11 10:50:06