Predicting Functional Outcome and Response to Therapy of Anti-NMDAR Encephalitis at Diagnosis

NCT ID: NCT06023160

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

714 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-07-01

Brief Summary

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The goal of this international cohort study is to develop a prediction model for long-term outcome and response to first-line immunotherapy of anti-NMDAR Encephalitis, already at the moment of diagnosis.

Detailed Description

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Anti-NMDARE is a severe, but treatable neurological condition, with considerable and variable long-term disability. The previously developed anti-NMDAR Encephalitis One-Year Functional Status (NEOS) score predicts outcome a month into treatment. To predict outcome and response to immunotherapy at the time of diagnosis would be a serious improvement. This would timely identify patients in need for aggressive treatment and avoid harmful side-effects in those with good outcome. International data from five anti-NMDAR encephalitis cohorts will be combined to attain these goals.

The investigators strive to have less than 10% missing data on all variables and will impute data were needed. The datasets will then be split - with equal distributions of cohorts and good/poor outcome - to develop (70%) and validate (30%) the NEOS2 model. The primary outcome is functioning one year after diagnosis. A secondary analysis is targeted to predict the effect of first-line therapy. Potentially relevant predictive variables are identified with a univariable analysis on the original data, confirmed with backwards selection on the imputed datasets. After checking for multicollinearity and linearity of the variables, identified variables are added to a mixed effects logistic regression model on the original and imputed datasets, to identify the final set of predictive variables. To make the models opportune for daily medical practice, the investigators will assign points to (categories of) the included variables, based on the coefficients.

Conditions

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Anti-NMDA (N-Methyl D-Aspartate) Receptor Encephalitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dutch National anti-NMDAR Encephalitis Cohort

Dutch National anti-NMDAR Encephalitis Cohort

No interventions assigned to this group

German anti-NMDAR Encephalitis Cohort (GENERATE)

German anti-NMDAR Encephalitis Cohort (GENERATE)

No interventions assigned to this group

Spanish anti-NMDAR Encephalitis Cohort

Spanish anti-NMDAR Encephalitis Cohort

No interventions assigned to this group

French anti-NMDAR Encephalitis Cohort

French anti-NMDAR Encephalitis Cohort

No interventions assigned to this group

Japanese anti-NMDAR Encephalitis Cohort

Japanese anti-NMDAR Encephalitis Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with anti-NMDAR encephalitis (according to the Graus criteria)

Exclusion Criteria

* Preceding Herpes Simplex encephalitis
* Premorbid dependency (modified Rankin Scale \> 2)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. Maarten J. Titulaer. MD, PhD

Associate professor, Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarten J. Titulaer, Assoc. Porf.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NEOSII

Identifier Type: -

Identifier Source: org_study_id

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