A Multicentric Cohort of Autoimmune Encephalitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: baseline data collection and follow-up.
- Who it may be relevant to
- Registry conditions: Autoimmune Encephalitis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicentric Registry Study of Autoimmune Encephalitis
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in modified Rankin score (mRS) from baseline [Time frame: 3months, 6 months, 12months, 24months]
Secondary outcome measures (3)
- Proportion of Subjects With Occurrence [Time frame: 12 months, 24 months]
- Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline [Time frame: 3months, 6 months, 12months, 24months]
- Changes of pathogenic antibody titers from baseline [Time frame: 3months, 6 months, 12months, 24months]
Eligibility criteria
Inclusion criteria
- 1\. 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.
Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.
Exclusion criteria
- No additional exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06760091 · XMEC-2024-003