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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05953974
Collaborator
(none)
350
1
5.9
59.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical score of Granillo and al.

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin
Actual Study Start Date :
Feb 1, 2023
Actual Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Validation of a diagnostic score for encephalitis to assess the risk of autoimmune origin. [At baseline]

    Comorbidities assessed by the Charlson score

  2. Symptoms in the acute phase [At baseline]

  3. Mode of onset of disease [At baseline]

  4. Results of lumbar puncture [At baseline]

  5. Results of antineuronal antibodies in CSF [At baseline]

  6. Results of antineuronal antibodies in serum [At baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes Lyon France

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05953974
Other Study ID Numbers:
  • 69HCL23_0627
First Posted:
Jul 20, 2023
Last Update Posted:
Jul 20, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2023