Risk Prediction Model for Severe Autoimmune Encephalitis

Not yet recruiting

• Conditions: Severe Autoimmune Encephalitis

• Registration Number: NCT06697678
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-01
• Primary Completion: 2028-02-29
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CASE	2 months of enrollment	The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.

Secondary Outcome Measures

Name	Time	Method
CASE	1 month of enrollment	The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
mRS	1 months, 2 months of enrollment	The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
GCS	1 months, 2 months of enrollment	The unabbreviated scale title is Glasgow coma score. The GCS tested 3 components: eye opening response, verbal response and motor response, with a total score of 15. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
Prognostic scores (CASE)	6 months, 12 months of enrollment	The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Prognostic scores (mRS)	6 months, 12 months of enrollment	The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.