Risk Prediction Model for Severe Autoimmune Encephalitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational Cohort.
- Who it may be relevant to
- Registry conditions: Severe Autoimmune Encephalitis. Basic parameters: 14 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis
Overview
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.
Interventions
- Other No Intervention: Observational Cohort
No intervention
Primary outcome measures
- CASE [Time frame: 2 months of enrollment]
Secondary outcome measures (5)
- CASE [Time frame: 1 month of enrollment]
- mRS [Time frame: 1 months, 2 months of enrollment]
- GCS [Time frame: 1 months, 2 months of enrollment]
- Prognostic scores (CASE) [Time frame: 6 months, 12 months of enrollment]
- Prognostic scores (mRS) [Time frame: 6 months, 12 months of enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06697678 · AE