fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226324
• Other study ID #: AHInnerMongolia-SLE
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: The Affiliated Hospital of Inner Mongolia Medical University
• Contact: Peng fei Qiao
• Phone: 15904718239
• Email: 24853170[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• neuropsychological test
The subjects were evaluated for memory, cognition, mood and sleep

Locations

Country	Name	City	State
China	Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Inner Mongolia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus	Early identification of specific brain areas of brain injury in lupus patients by fMRI provides objective imaging markers for early clinical intervention.	2 years