An observational study in Severe Autoimmune Encephalitis, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Xuanwu Hospital, Beijing · Observational
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A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.
To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.
123 studies on the registry are indexed under Autoimmune Diseases of the Nervous System; 59 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 160 across 57 observational studies indexed under Autoimmune Diseases of the Nervous System.
Browse Autoimmune Diseases of the Nervous System studies →Xuanwu Hospital, Beijing is the lead sponsor of 364 studies on the registry; 230 are open to participants now.
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Diagnostic criteria for autoimmune encephalitis (AE) patients (all four criteria must be met): A. clinical Presentation: acute or subacute onset (\<3 months) with one or more neurological or psychiatric symptoms or clinical syndromes: a. limbic system symptoms b. encephalitis syndrome c. basal ganglia and/or diencephalon/hypothalamus involvement d. psychiatric disorders. B. auxiliary tests: presence of one or more of the following findings, or associated relevant tumors: a. abnormal cerebrospinal fluid (CSF) b. neuroimaging or electrophysiological abnormalities. C. confirmatory test: positive neuronal autoantibodies. D. exclusion of other causes: a reasonable exclusion of other potential etiologies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Other: No Intervention: Observational Cohort
Other: No Intervention: Observational Cohort
No intervention
CASE
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Time frame: 2 months of enrollment
CASE
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Time frame: 1 month of enrollment
mRS
The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
Time frame: 1 months, 2 months of enrollment
GCS
The unabbreviated scale title is Glasgow coma score. The GCS tested 3 components: eye opening response, verbal response and motor response, with a total score of 15. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
Time frame: 1 months, 2 months of enrollment
Prognostic scores (CASE)
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Time frame: 6 months, 12 months of enrollment
Prognostic scores (mRS)
The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
Time frame: 6 months, 12 months of enrollment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Feb 2028, 37 months later.
Of 28 observational studies under Autoimmune Diseases of the Nervous System, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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