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Risk Prediction Model for Severe Autoimmune Encephalitis

Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06697678
Enrollment
1000
Registered
2024-11-20
Start date
2025-01-01
Completion date
2028-12-31
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Autoimmune Encephalitis

Keywords

severe autoimmune encephalitis, prediction model, plasma exchange therapy, plasma adsorption therapy, targeted immunotherapy

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.

Interventions

OTHERNo Intervention: Observational Cohort

No intervention

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CASE2 months of enrollmentThe 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

MeasureTime frameDescription
CASE1 month of enrollmentThe 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.
mRS1 months, 2 months of enrollmentThe unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
GCS1 months, 2 months of enrollmentThe 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 enrollmentThe 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 enrollmentThe unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.

Contacts

Primary ContactYan Zhang
zhangylq@sina.com0086-13671376710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026