Neuro-ophthalmology and Autoimmune Encephalitis (NODE)

Autoimmune Encephalitis Clinical Trial

— NODE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03872284
• Other study ID #: 69HCL18_0749
• Secondary ID: 2019-A00684-53
• Status: Recruiting
• Start date: January 22, 2020
• Est. completion date: January 24, 2027

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Caroline Tilikete, Prof.
• Phone: 4 72 11 93 84
• Email: caroline.tilikete[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 24, 2027
• Est. primary completion date: January 24, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

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).

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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