A Multicentric Cohort of Autoimmune Encephalitis
ConditionAutoimmune Encephalitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No additional exclusion criteria
Trial population
Patients with autoimmune encephalitis or paraneoplastic neurological syndrome will be enrolled and no additional exclusion criteria are set.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
baseline data collection and follow-up
Other interventionAt 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: autoimmune encephalitis group1 intervention
Trial outcomes
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).
Time frame
3months, 6 months, 12months, 24monthsSecondary outcomes
1
Proportion of Subjects With Occurrence
Time frame
12 months, 24 months2
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.
Time frame
3months, 6 months, 12months, 24months3
Changes of pathogenic antibody titers from baseline
Time frame
3months, 6 months, 12months, 24monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: