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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT05825690
Collaborator
(none)
50
1
6
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Retrospective evaluation of specific brain MRI features

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Investigating the Prognostic Role of Brain MRI in Anti-LGI1 Encephalitis
Actual Study Start Date :
Jun 20, 2022
Actual Primary Completion Date :
Sep 20, 2022
Actual Study Completion Date :
Dec 20, 2022

Arms and Interventions

Arm Intervention/Treatment
LGI1- Patients

Patients affected by autoimmune encephalitis with antibodies against LGI1

Other: Retrospective evaluation of specific brain MRI features
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

Outcome Measures

Primary Outcome Measures

  1. Cognitive dysfunction and disability [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
    • Patients with a definite diagnosis of LGI1-antibody-associated encephalitis
  • available MRI records

  • Ascertained positivity for LGI1-antibodies in serum and/or CSF

Exclusion Criteria:
    • Positivity for another antibody against neural or glial antigens
  • MRI images not available

  • Not enough clinical data to ascertain outcome

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes Lyon 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:
NCT05825690
Other Study ID Numbers:
  • 22-5017
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
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 Apr 24, 2023