Clinical trial NCT06697678: Risk Prediction Model for Severe Autoimmune Encephalitis
Official title: Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Autoimmune Encephalitis
Keywords: severe autoimmune encephalitis
prediction model
plasma exchange therapy
plasma adsorption therapy
targeted immunotherapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnostic criteria for autoimmune encephalitis (AE) patients (all four criteria must be met): A. clinical Presentation: acute or subacute onset (\<3 months) with one or more neurological or psychiatric symptoms or clinical syndromes: a. limbic system symptoms b. encephalitis syndrome c. basal ganglia and/or diencephalon/hypothalamus involvement d. psychiatric disorders. B. auxiliary tests: presence of one or more of the following findings, or associated relevant tumors: a. abnormal cerebrospinal fluid (CSF) b. neuroimaging or electrophysiological abnormalities. C. confirmatory test: positive neuronal autoantibodies. D. exclusion of other causes: a reasonable exclusion of other potential etiologies.

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.

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

Primary outcomes:
measure: CASE
timeFrame: 2 months of enrollment
Secondary outcomes:
measure: CASE
timeFrame: 1 month of enrollment
measure: mRS
timeFrame: 1 months, 2 months of enrollment
measure: GCS
timeFrame: 1 months, 2 months of enrollment
measure: Prognostic scores (CASE)
timeFrame: 6 months, 12 months of enrollment
measure: Prognostic scores (mRS)
timeFrame: 6 months, 12 months of enrollment
Other outcomes:
Locations:
Study officials:
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