A Multicentric Cohort of Autoimmune Encephalitis

NCT06760091 | Not Yet Recruiting

• 1 other identifier: XMEC-2024-003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

autoimmune encephalitis group

Other: baseline data collection and follow-up

Interventions

baseline data collection and follow-up OTHER

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.

autoimmune encephalitis group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Gender and age are not limited; 2. 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) 3. The patient or legal representative voluntarily signed the paper informed consent form.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The biological samples of enrolled patients, such as blood, cerebrospinal fluid and teratoma samples.

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Junwei Hao, MD; PhD

CONTACT

01083198277; haojunwei@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)