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临床试验/NCT06226324
NCT06226324招募中不适用

fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

The Affiliated Hospital of Inner Mongolia Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

研究概览

简要总结

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs and systems. The central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of SLE and the main cause of death. Cognitive impairment and emotional disorders are the most common neuropsychiatric symptoms, with a prevalence of up to 80%. Studies have shown that the prevalence of NPSLE is between 37% and 95%. Compared with SLE patients, the mortality rate increases by three times. Early diagnosis and treatment play an important role in improving the quality of life of patients. fMRI has the advantages of non-invasive, in vivo and high repeatability, and can detect the brain function changes of patients early before the structural changes. This study uses fMR to compare the differences in brain function changes between SLE patients and healthy controls, explore the neuroimaging mechanism of brain injury, and provide reference for the early clinical intervene.

详细描述

The fMRI images of 40 SLE patients with neuropsychiatric symptoms, 40 SLE patients without neuropsychiatric symptoms and 40 healthy controls matched by sex, age and education level were collected. fMRI was selected as an evaluation method to compare the differences in brain functional changes among the three groups, and to explore the specific brain regions in the imaging of early brain injury in SLE. Neurocognitive assessment was performed on all subjects, clinical data and laboratory serum markers of SLE patients were collected, and the correlation between SLE patients and specific brain regions was analyzed, and multiple regression models were constructed to provide imaging references for early clinical diagnosis and intervention in the process of NPSLE.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age and gender matched the case group
  • Right-handed
  • No cerebrovascular, neurological or mental diseases
  • Can cooperate with MRI and neuropsychiatric examination

排除标准

  • Patients with serious diseases of other systems
  • Patients with diseases of central nervous system
  • Other rheumatic immune system diseases
  • Neuropsychiatric history
  • Smokers, drug users or alcoholics
  • Contraindicated MRI

结局指标

主要结局

fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

时间窗: 2 years

Early identification of specific brain areas of brain injury in lupus patients by fMRI provides objective imaging markers for early clinical intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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