Clinical trial NCT06226324: fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
Official title: fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Lead sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There were 80 SLE patients (40 with and without neuropsychiatric symptoms) and 40 healthy controls

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
Study officials:
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Peng fei Qiao
role: STUDY_DIRECTOR
References: