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Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05607368
Collaborator
(none)
45
Enrollment
1
Location
48
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is a prospective cohort study: it is proposed to be divided into 3 groups, namely healthy control group and SLE group, NPSLE epilepsy group; Fifteen cases were included in each group, with the consent of the subjects and signed to know Consent form, record all subjects' clinical and laboratory test data, and test subjects' blood. Markers such as cerebrospinal fluid tryptase, TLR4 and anti-NR2A antibodies, follow-up 2 year, the patient's disease activity is evaluated every year, the change of indicators is dynamically observed, and statistical points are made divide.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    45 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    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 and neurological symptoms and 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.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in disease activity index [Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24]

      SLEDAI

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. 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.

    1. 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.

    1. 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.

    Exclusion Criteria:
    1. 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.

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qin Huang Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Nanfang Hospital of Southern Medical University

    Investigators

    • Principal Investigator: Qin Huang, Doctor, Southern Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HUNAG QIN, Clinical Professor, Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT05607368
    Other Study ID Numbers:
    • NFEC-2022-005
    First Posted:
    Nov 7, 2022
    Last Update Posted:
    Nov 7, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Epilepsy
    Lupus Erythematosus, Systemic

    Study Results

    No Results Posted as of Nov 7, 2022