LGI1-antibody Patients Follow-up (evoLGI1)

October 11, 2019 updated by: Hospices Civils de Lyon

Clinical, EEG and Radiological Initial and Evolutive Characterisation of LGI1-antibody Patients

Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders.

This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study Population Description : Adult patients presenting an anti-LGI1 autoimmune encephalitis, followed in France and diagnosed by sera or CSF samples at the National Reference Center of autoimmune encephalitis.

Description

Inclusion Criteria:

  • Age > 18 years
  • Diagnosis of anti-LGI1 encephalitis based on sera or CSF samples in the National Reference Center of autoimmune encephalitis from 2011/06 to 2019 july 1st.
  • Clinical follow-up in France

Exclusion Criteria:

  • Anti-LGI1 antibody associated with another encephalitis antibody
  • Foreign follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
: epileptic LGI1-antibody patients

Patients affected by LGI1 antibody encephalitis presenting epileptic seizures as a first symptom

Evaluated items:

  • Number of seizures
  • Type of seizures
  • Presence of EEG abnormalities
  • Presence of IRM abnormalities
  • Time before cognitive disorders
cognitive LGI1-antibody patients

Patients affected by LGI1 antibody encephalitis presenting cognitive disorders as a first symptom

Evaluated items:

  • Presence of EEG abnormalities
  • Presence of IRM abnormalities
  • Time before epileptic seizures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of epileptic seizures
Time Frame: 12 MONTHS
12 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jerome HONNORAT, pHd, National Reference Center of autoimmune encephalitis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2019

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • evoLGI1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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