Clincosm LogoSign in Get a demo

Neuro-ophthalmology and Autoimmune Encephalitis (NODE)

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03872284
Collaborator
(none)
70
Enrollment
1
Location
84.1
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: oculomotor movement recordings, neurovisual assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)
Actual Study Start Date :
Jan 22, 2020
Anticipated Primary Completion Date :
Jan 24, 2027
Anticipated Study Completion Date :
Jan 24, 2027

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients presenting a neuro-ophthalmological abnormality. [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.

  2. Percentage of patients presenting neuro-ophthalmological abnormality. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03872284
Other Study ID Numbers:
  • 69HCL18_0749
  • 2019-A00684-53
First Posted:
Mar 13, 2019
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Encephalitis
Hashimoto Disease

Study Results

No Results Posted as of Mar 22, 2022