A Multicentric Cohort of Autoimmune Encephalitis

Multicentric Registry Study of Autoimmune Encephalitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autoimmune Encephalitis
• Intervention / Treatment: Other: baseline data collection and follow-up

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Junwei Hao, MD; PhD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University
    • Contact: Junwei Hao, MD,PhD; Phone Number: 01083198277; Email: haojunwei@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune encephalitis or paraneoplastic neurological syndrome will be enrolled and no additional exclusion criteria are set.

Description

Inclusion Criteria:

• 1. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:

  1. According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
  2. 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
  3. According to the criteria of Graus et al in 2021, diagnosed as "possible or definite paraneoplastic neurological syndrome" (excluding peripheral nervous system syndrome) 3. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
autoimmune encephalitis group	Other: baseline data collection and follow-up; At the time of enrollment, baseline characteristics will be collected, and each subject will be followed up for 2 years through face-to-face, telephone, or online visits. During the follow-up period, the clinical prognosis will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in modified Rankin score (mRS) from baseline	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).	3months, 6 months, 12months, 24months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Occurrence		12 months, 24 months
Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline	The Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score is designed specifically to assess the severity of autoimmune disease. It is a general scoring system ranging from 0 to 27 and can be used as an alternative tool to assess the severity of patients with AE more accurately. Higher scores mean a worse clinical status.	3months, 6 months, 12months, 24months
Changes of pathogenic antibody titers from baseline		3months, 6 months, 12months, 24months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Thyroiditis; Encephalitis; Autoimmune Diseases of the Nervous System; Hashimoto Disease
• Other Study ID Numbers: XMEC-2024-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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