Clinical-immunological Features of Anti-NMDAR Encephalitis

NCT05738668 | Unknown

• 1 other identifier: 750
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anti NMDA Receptor Encephalitis

Keywords

Anti NMDA Receptor Encephalitis; antibodies; relapses; outcomes

Outcome Measures

Primary Outcomes (1)

• Modified Rankin scale (mRS)

  Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

  Baseline

Study Arms (1)

Anti-NMDAR encephalitis

Patients with well-characterized anti-NMDAR encephalitis.

Other: Description of clinical characteristic

Interventions

Description of clinical characteristic OTHER

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.

Anti-NMDAR encephalitis

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with well-characterized anti-NMDAR encephalitis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est

Lyon, BRON, 69677, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, DNA, cells, CSF collected at diagnosis time

MeSH Terms

Conditions

Anti-N-Methyl-D-Aspartate Receptor Encephalitis; Recurrence

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: February 22, 2023
• Study Start: February 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: February 1, 2025
• Last Updated: February 22, 2023

Record last verified: 2022-09

Locations

FR (1)