BRIEF TITLE * (in English and Sufficiently Descriptive) Role of MRI in Anti-LGI1 Encephalitis

NCT05825690 | Completed

• 1 other identifier: 22-5017
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The term "autoimmune encephalitis" denotes an heterogenous group of diseases commonly associated with autoantibodies targeting neural or glial antigens. Patients harboring antibodies against the leucine-rich glioma-inactivated protein 1 (LGI1) usually respond well to immunotherapy, but a significant percentage develop cognitive sequelae and disability nonetheless. These patients would likely benefit for more aggressive and prolonged immunotherapy, aiming to prevent permanent neurological deficits. Identifying features predicting poor outcome would be crucial to guide treatment decisions. Brain magnetic resonance imaging is a key diagnostic tool in the acute phase, but radiological changes may also appear in follow-up studies, including global brain atrophy, hippocampal atrophy and mesial temporal sclerosis. We hypothesize that specific changes identifiable in the acute and chronic phase underlie a higher risk of poor outcome and persistent neurological deficits.

Conditions

Autoimmune Encephalitis

Keywords

Autoimmune encephalitis; LGI1 antibodies; MRI

Outcome Measures

Primary Outcomes (1)

• Cognitive dysfunction and disability

  Main outcome measures will include cognitive dysfunction measured by appropriate neuropsychological evaluations, and psychiatric symptoms; it will be "none", "light", "moderate", "severe"

  12 months

Study Arms (1)

LGI1- Patients

Patients affected by autoimmune encephalitis with antibodies against LGI1

Other: Retrospective evaluation of specific brain MRI features

Interventions

Retrospective evaluation of specific brain MRI features OTHER

Initial brain MRI and subsequent follow-up studies will be reviewed to document the presence of specific MRI features, and their association with greater disease severity in the acute phase and/or neurological sequelae after encephalitis resolution will be investigated. More specifically, we will analyze the presence of: * Brain MRI changes in the acute stage, i.e. \< 3 months from symptoms onset, including abnormal signal intensity, altered diffusion and/or contrast enhancement in the hippocampus (unilateral/bilateral), abnormal signal intensity in basal ganglia, insula, and/or perisylvian cortex, presence of global brain atrophy, presence of hippocampal atrophy and/or MTS, hippocampal volumetry * Brain MRI changes after acute phase resolution (\> 6 months after symptoms onset) including abnormal signal intensity in the hippocampus (unilateral/bilateral), presence of global brain atrophy, presence of hippocampal atrophy and/or MTS, hippocampal volumetry

LGI1- Patients

Eligibility Criteria

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

Study Population

Patients will be included from the from the database of the French Reference Centre for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (Lyon, France)

You may qualify if:

• \- Patients with a definite diagnosis of LGI1-antibody-associated encephalitis
• available MRI records
• Ascertained positivity for LGI1-antibodies in serum and/or CSF

You may not qualify if:

• \- Positivity for another antibody against neural or glial antigens
• MRI images not available
• Not enough clinical data to ascertain outcome

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Lyon, 69677, France

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 24, 2023
• Study Start: June 20, 2022
• Primary Completion: September 20, 2022
• Study Completion: December 20, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

FR (1)