fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: neuropsychological test

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Peng fei Qiao; Phone Number: 15904718239; Email: 24853170@qq.com

Study Locations

• China
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Recruiting
      • Affiliated Hospital of Inner Mongolia Medical University
      • Contact: Peng fei Qiao; Phone Number: 15904718239; Email: 24853170@qq.com
      • Principal Investigator: Peng fei Qiao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

There were 80 SLE patients (40 with and without neuropsychiatric symptoms) and 40 healthy controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLE with neuropsychiatric symptoms; Neuropsychiatric symptoms meeting the 1999 ACR definition; Ages 18-55y; Female; Right-handed; Can cooperate with MRI and neuropsychiatric examination	Other: neuropsychological test; The subjects were evaluated for memory, cognition, mood and sleep
SLE without neuropsychiatric symptoms; Patients who meet the 2019 ACR diagnostic criteria for SLE; Patients without neuropsychiatric symptoms; Age 18-55y; Female; Right-handed; Able to cooperate with MRI and neuropsychiatric examination	Other: neuropsychological test; The subjects were evaluated for memory, cognition, mood and sleep
Healthy control group; Age and gender matched the case group; Right-handed; No cerebrovascular, neurological or mental diseases; Can cooperate with MRI and neuropsychiatric examination	Other: neuropsychological test; The subjects were evaluated for memory, cognition, mood and sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Inner Mongolia Medical University
• Investigators: Study Director: Peng fei Qiao, Affiliated Hospital of Inner Mongolia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Wounds and Injuries; Connective Tissue Diseases; Craniocerebral Trauma; Trauma, Nervous System; Lupus Erythematosus, Systemic; Brain Injuries
• Other Study ID Numbers: AHInnerMongolia-SLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No