Risk Prediction Model for Severe Autoimmune Encephalitis

NCT06697678 | Not Yet Recruiting DMC

• 1 other identifier: AE
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Severe Autoimmune Encephalitis

Keywords

severe autoimmune encephalitis; prediction model; plasma exchange therapy; plasma adsorption therapy; targeted immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months of enrollment

Secondary Outcomes (5)

• CASE

  1 month of enrollment

• mRS

  1 months, 2 months of enrollment

• GCS

  1 months, 2 months of enrollment

• Prognostic scores (CASE)

  6 months, 12 months of enrollment

• Prognostic scores (mRS)

  6 months, 12 months of enrollment

Study Arms (2)

patients with severe autoimmune encephalitis

No intervention

Other: No Intervention: Observational Cohort

patients with non-severe autoimmune encephalitis

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

patients with non-severe autoimmune encephalitis; patients with severe autoimmune encephalitis

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• age 14-80 years
• no restriction on gender
• meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
• within 3 months of AE
• patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf

You may not qualify if:

• no lumbar puncture performed for CSF antibody testing
• did not receive immunotherapy
• pre-onset modified Rankin Scale (mRS) score ≥3

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yan Zhang

CONTACT

0086-13671376710; zhangylq@sina.com

Study Design

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

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12