Investigating the role of mast cells in epilepsy related to systemic lupus erythematosus

Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy

This study looks at how mast cells might be involved in epilepsy for people with systemic lupus erythematosus to see if they can help find new treatment options.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05607368 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the involvement of mast cells in the mechanism of epilepsy associated with systemic lupus erythematosus (NPSLE). It will include three groups: healthy controls, patients with systemic lupus erythematosus, and patients with NPSLE epilepsy, with 15 participants in each group. Researchers will measure various biomarkers, including tryptase, TLR4, and anti-NR2A antibodies, in serum and cerebrospinal fluid over a two-year follow-up period to assess their relevance to disease activity and identify potential therapeutic targets. The study will dynamically observe changes in these indicators and evaluate the patients' disease activity annually.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals aged 18-50, patients diagnosed with systemic lupus erythematosus, and those with NPSLE epilepsy within the same age range.

Not a fit: Patients with systemic lupus erythematosus who also have other autoimmune diseases or a history of seizures or psychiatric abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic targets that improve the prognosis and quality of life for patients with systemic lupus erythematosus.

How similar studies have performed: While this study explores a specific mechanism in NPSLE epilepsy, similar studies have shown promise in understanding the role of immune cells in neurological conditions, suggesting potential for success.

Eligibility criteria

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.
2. 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.
3. 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.
2. 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.

Where this trial is running

Guangzhou, Guangdong

• Qin Huang — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Qin Huang, Doctor — Southern Medical University
• Study coordinator: Qin Huang, Doctor

Conditions Lupus Erythematosus, Systemic