Bio-NMDAr: Clinical-immunological Features of Anti-NMDAR Encephalitis

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05738668

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers

Condition or Disease	Intervention/Treatment	Phase
Anti NMDA Receptor Encephalitis	Other: Description of clinical characteristic

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Clinical-immunological Features of Anti-NMDAR Encephalitis

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Anti-NMDAR encephalitis Patients with well-characterized anti-NMDAR encephalitis.	Other: Description of clinical characteristic This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.

Arm

Intervention/Treatment

Anti-NMDAR encephalitis

Patients with well-characterized anti-NMDAR encephalitis.

Other: Description of clinical characteristic

This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.

Outcome Measures

Primary Outcome Measures

Modified Rankin scale (mRS) [Baseline]
Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patient with neurological disorder
Patient with NMDAR antibodies in sera or CSF

Exclusion Criteria:

- No available clinical data
Patient without NMDAR antibodies or neurological disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est	Lyon	Bron	France	69677

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:

NCT05738668

Other Study ID Numbers:

First Posted:

Feb 22, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Anti NMDA Receptor Encephalitis

antibodies

relapses

outcomes

Additional relevant MeSH terms:

Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Encephalitis

Study Results

No Results Posted as of Feb 22, 2023