Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin (Val-Dia score)

July 12, 2023 updated by: Hospices Civils de Lyon
The investigators wish to test a diagnostic risk score for autoimmune encephalitis in case of encephalitis, previously validated by two American teams, in a retrospective analysis, according to the clinical and paraclinical data available in our database of the Reference Centre for Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes of Professor Honnorat for patients with NMDAr, anti LGi1, anti CASPR2, anti GABAbr and anti GAD antibodies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France
        • Recruiting
        • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :

  • Anti NMDAr
  • Anti LGI1
  • Anti CASPR2
  • Anti GABAb
  • Anti GAD

Description

Inclusion Criteria:

  • Age > 18 years old
  • Patient with a definite auto-immune encephalitis (Graus and al. 2016)

Exclusion Criteria:

  • Uncomplete data in acute phase
  • Patient with several antibodies
  • Opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NMDAr patients

Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :

- Anti NMDAr
Other: Clinical score of Granillo and al.
Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.
LGI1 patients

Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :

- Anti LGI1
Other: Clinical score of Granillo and al.
Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.
CASPR2 patients

Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :

- Anti CASPR2
Other: Clinical score of Granillo and al.
Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.
GABAb patients

Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :

- Anti GABAb
Other: Clinical score of Granillo and al.
Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.
GAD patients

Patients > or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies :

- Anti GAD
Other: Clinical score of Granillo and al.
Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of a diagnostic score for encephalitis to assess the risk of autoimmune origin.
Time Frame: At baseline
Comorbidities assessed by the Charlson score
At baseline
Symptoms in the acute phase
Time Frame: At baseline
At baseline
Mode of onset of disease
Time Frame: At baseline
At baseline
Results of lumbar puncture
Time Frame: At baseline
At baseline
Results of antineuronal antibodies in CSF
Time Frame: At baseline
At baseline
Results of antineuronal antibodies in serum
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 1, 2023

Study Completion (Estimated)

July 30, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autoimmune Encephalitis

Clinical Trials on Clinical score of Granillo and al.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe