Neuro-ophthalmology and Autoimmune Encephalitis (NODE)

NCT03872284 | Completed

• 2 other identifiers: 69HCL18_07492019-A00684-53
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis

Outcome Measures

Primary Outcomes (2)

• Percentage of patients presenting a neuro-ophthalmological abnormality.

  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.

  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

Study Arms (1)

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

Interventions

oculomotor movement recordings, neurovisual assessment OTHER

Each participant will have a neurovisual assessment and an oculomotor movement recording with an eye tracker (infra red cameras).

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Caroline Tilikete, Prof.

  Department of neuro-ophthalmology, Pierre Wertheimer university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: January 22, 2020
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)