fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

NCT06226324 | Unknown

• 1 other identifier: AHInnerMongolia-SLE
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Other: neuropsychological test

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

Other: neuropsychological test

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

Other: neuropsychological test

Interventions

neuropsychological test OTHER

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

Healthy control group; SLE with neuropsychiatric symptoms; SLE without neuropsychiatric symptoms

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Inner Mongolia Medical University: lead

Study Sites (1)

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

RECRUITING

Related Publications (1)

• Ni S, An N, Li C, Ma Y, Qiao P, Ma X. Altered structural and functional homotopic connectivity associated with cognitive changes in SLE. Lupus Sci Med. 2024 Nov 24;11(2):e001307. doi: 10.1136/lupus-2024-001307.

  PMID: 39581701 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Peng fei Qiao

  The Affiliated Hospital of Inner Mongolia Medical University

  STUDY DIRECTOR

Central Study Contacts

Peng fei Qiao

CONTACT

15904718239; 24853170@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 26, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

CN (1)