Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy

NCT05607368 | Unknown

• 1 other identifier: NFEC-2022-005
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (2)

• Changes in disease activity index

  SLEDAI

  Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24

• Numerical changes in markers such as tryptase, TLR4, and anti-NR2A antibodies in blood and cerebrospinal fluid

  Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24

Study Arms (3)

SLE group

1. Voluntary signing of informed consent; 2. Age greater than 18 years old, less than 50 years old, gender is not limited; 3. Patients with SLE who meet diagnostic criteria.

NPSLE epilepsy group

1. Voluntary signing of informed consent. 2. Age greater than 18 years old, less than 50 years old, gender is not limited. 3. Patients with NPSLE epilepsy who meet diagnostic criteria.

Healthy control group

1. Voluntary signing of informed consent; 2. Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender; 3. No systemic diseases and neurological symptoms and signs; 4. According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Nanfang Hospital presents patients with systemic lupus erythematosus (SLE) and neuropsychiatric lupus(NPSLE) patients with epilepsy, as well as health examinations at the Health Management Center of Southern Hospital Healthy subjects

You may qualify if:

• Healthy control group
• Voluntary signing of informed consent;
• Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender;
• No systemic diseases or neurological symptoms or signs;
• According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group.
• SLE group
• Voluntary signing of informed consent;
• Age greater than 18 years old, less than 50 years old, gender is not limited;
• Patients with SLE who meet diagnostic criteria.
• NPSLE Epilepsy Group
• Voluntary signing of informed consent;
• Age greater than 18 years old, less than 50 years old, gender is not limited;
• Patients with NPSLE epilepsy who meet diagnostic criteria.

You may not qualify if:

• SLE group
• patients with SLE with other autoimmune diseases;
• Previous seizures, psychiatric abnormalities and other manifestations;
• MR of the head has obvious abnormal signals in the skull or EEG shows abnormal signals;
• History of use of hormones and immunosuppressants;
• The investigators judged that it was not suitable to participate in this study.
• NPSLE Epilepsy Group
• prior history of epilepsy or clear cranial MR findings suggesting structural abnormalities;
• Presence of precipitating seizures such as sleep deprivation, high fever, infection, long-term abstinence from alcoholism
• Interrupt, patients with systemic diseases such as hypoglycemia, severe electrolyte disorders, malignant lesions, progressive or degenerative diseases, severe liver and kidney insufficiency and other metabolic diseases;
• The investigators judged that it was not suitable to participate in this study.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Qin Huang

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Study Officials

• Qin Huang, Doctor

  Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Huang, Doctor

CONTACT

13632430850; qinzihq@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 7, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 7, 2022

Record last verified: 2022-10

Locations

CN (1)