Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin

Autoimmune Encephalitis Clinical Trial

— Val-Dia score  

Official title:

Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05953974
• Other study ID #: 69HCL23_0627
• Status: Active, not recruiting
• Start date: February 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

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.

Locations

Country	Name	City	State
France	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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