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NCT Number: NCT06697678

Risk Prediction Model for Severe Autoimmune Encephalitis

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.

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. CASE

    Time frame: 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 outcomes

  1. CASE

    Time frame: 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.

  2. mRS

    Time frame: 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.

  3. GCS

    Time frame: 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.

  4. Prognostic scores (CASE)

    Time frame: 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.

  5. Prognostic scores (mRS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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