Multicentric Registry Study of Autoimmune Encephalitis

Xuanwu Hospital, Beijing1 site in 1 country200 target enrollmentFebruary 1, 2025

ConditionsAutoimmune Encephalitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autoimmune Encephalitis
Sponsor: Xuanwu Hospital, Beijing
Enrollment: 200
Locations: 1
Primary Endpoint: Change in modified Rankin score (mRS) from baseline
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.

Registry

clinicaltrials.gov

Start Date

February 1, 2025

End Date

December 31, 2028

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Xuanwu Hospital, Beijing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Gender and age are not limited;
•Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:
•According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
•According to the criteria of Graus et al in 2016, diagnosed as "possible autoimmune encephalitis" and typical autoantibodies are detected in serum or cerebrospinal fluid
•According to the criteria of Graus et al in 2021, diagnosed as "possible or definite paraneoplastic neurological syndrome" (excluding peripheral nervous system syndrome)
•The patient or legal representative voluntarily signed the paper informed consent form.
•Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.

Exclusion Criteria

•No additional exclusion criteria

Outcomes

Primary Outcomes

Change in modified Rankin score (mRS) from baseline

Time Frame: 3months, 6 months, 12months, 24months

Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).

Secondary Outcomes

Proportion of Subjects With Occurrence(12 months, 24 months)
Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline(3months, 6 months, 12months, 24months)
Changes of pathogenic antibody titers from baseline(3months, 6 months, 12months, 24months)