Risk Prediction Model for Severe Autoimmune Encephalitis

Capital Medical University

Status: Not yet enrolling

Conditions: Severe Autoimmune Encephalitis

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT06697678

AE

Details and patient eligibility

About

A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.

Full description

To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 14-80 years
• no restriction on gender
• meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
• within 3 months of AE
• patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf

Exclusion criteria

• no lumbar puncture performed for CSF antibody testing
• did not receive immunotherapy
• pre-onset modified Rankin Scale (mRS) score ≥3

Trial design

1,000 participants in 2 patient groups

patients with severe autoimmune encephalitis

Description:

No intervention

Treatment:

Other: No Intervention: Observational Cohort

patients with non-severe autoimmune encephalitis

Treatment:

Other: No Intervention: Observational Cohort