Risk Prediction Model for Severe Autoimmune Encephalitis

December 20, 2024 updated by: Xuanwu Hospital, Beijing

Development and Validation of a 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with severe autoimmune encephalitis
No intervention
Other: No Intervention: Observational Cohort
No intervention
patients with non-severe autoimmune encephalitis
Other: No Intervention: Observational Cohort
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month of enrollment
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.
1 months, 2 months of enrollment
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.
1 months, 2 months of enrollment
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.
6 months, 12 months of enrollment
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.
6 months, 12 months of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

study protocol can be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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