fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SLE with neuropsychiatric symptoms

1. Neuropsychiatric symptoms meeting the 1999 ACR definition
2. Ages 18-55y
3. Female
4. Right-handed
5. Can cooperate with MRI and neuropsychiatric examination

neuropsychological test

Intervention Type OTHER

The subjects were evaluated for memory, cognition, mood and sleep

SLE without neuropsychiatric symptoms

1. Patients who meet the 2019 ACR diagnostic criteria for SLE
2. Patients without neuropsychiatric symptoms
3. Age 18-55y
4. Female
5. Right-handed
6. Able to cooperate with MRI and neuropsychiatric examination

neuropsychological test

Intervention Type OTHER

The subjects were evaluated for memory, cognition, mood and sleep

Healthy control group

1. Age and gender matched the case group
2. Right-handed
3. No cerebrovascular, neurological or mental diseases
4. Can cooperate with MRI and neuropsychiatric examination

neuropsychological test

Intervention Type OTHER

The subjects were evaluated for memory, cognition, mood and sleep

Interventions

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neuropsychological test

The subjects were evaluated for memory, cognition, mood and sleep

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age and gender matched the case group
2. Right-handed
3. No cerebrovascular, neurological or mental diseases
4. Can cooperate with MRI and neuropsychiatric examination

Exclusion Criteria

1. Patients with serious diseases of other systems
2. Patients with diseases of central nervous system
3. Other rheumatic immune system diseases
4. Neuropsychiatric history
5. Smokers, drug users or alcoholics
6. Contraindicated MRI

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes