Neuro-ophthalmology and Autoimmune Encephalitis (NODE) (NODE)

January 25, 2024 updated by: Hospices Civils de Lyon

Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)

Autoimmune encephalitis represents a group of rare and heterogeneous neurological disorders. Pathophysiological mechanisms in these diseases are still unknown. Recently, oculomotor and neurovisual disorders have been described. Cerebral areas and neuronal networks associated with these abnormalities are well described. The investigator proposes to study and describe such neuro-ophthalmological disorders in a prospective cohort of patients with a autoimmune encephalitis, to better understand the pathophysiological basis of this neurological condition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de LYON
        • Contact:
        • Principal Investigator:
          • Caroline TILIKETE, MD
        • Sub-Investigator:
          • Aude METZGER, MD

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men and women 18 to 70 years old diagnosed with autoimmune encephalitis

Description

Inclusion Criteria:

  • Diagnosis of autoimmune encephalitis
  • With or without pathological antibody
  • Aged from 18 to 70 years old
  • Able to understand the aims and methods of this project
  • Non opposed to the participation of this study

Exclusion Criteria:

  • Other neurological, psychiatric or systemic conditions, which could induce neuro-ophthalmological signs Cognitive impairment, which is not linked to autoimmune encephalitis
  • Ophthalmological condition, which could modify the interpretation of neuro-ophthalmological data Inability to remain seated
  • Pregnancy or breast feeding
  • Adults under guardianship

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients in the study group have a diagnosis of autoimmune encephalitis, are 18 to 70 years old, and have no significant comorbidity such as psychiatric, neurological conditions and able to understand the aim of this study.
Other: oculomotor movement recordings, neurovisual assessment
Each participant will have a neurovisual assessment and an oculomotor movement recording with an eye tracker (infra red cameras).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients presenting a neuro-ophthalmological abnormality.
Time Frame: Day 0
A neuro-ophthalmological disorder is defined as an abnormality in the oculo-motor movement recording or/and the presence of a neurovisual impairment.
Day 0
Percentage of patients presenting neuro-ophthalmological abnormality.
Time Frame: At 6 months if an abnormality is found
A neuro-ophthalmological disorder is defined as an abnormality in the oculo-motor movement recording or/and the presence of a neurovisual impairment.
At 6 months if an abnormality is found

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Caroline Tilikete, Prof., Department of neuro-ophthalmology, Pierre Wertheimer university hospital

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 (Actual)

January 22, 2020

Primary Completion (Estimated)

January 24, 2027

Study Completion (Estimated)

January 24, 2027

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0749
  • 2019-A00684-53 (Other Identifier: ID RDB)

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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