Skip to main content
OpenTrials
Completed

NCT Number: NCT05825690

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autoimmune Encephalitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Lyon, 69677, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Cognitive dysfunction and disability

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Investigating the Prognostic Role of Brain MRI in Anti-LGI1 Encephalitis

Acronym: LGI1-IRM

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.