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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03872284
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : August 8, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Autoimmune Encephalitis Other: oculomotor movement recordings, neurovisual assessment

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Group/Cohort Intervention/treatment
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).

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women 18 to 70 years old diagnosed with autoimmune encephalitis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03872284

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Contact: Caroline Tilikete, Prof. 4 72 11 93 84 ext 33

Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Caroline Tilikete, Prof. Department of neuro-ophthalmology, Pierre Wertheimer university hospital

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03872284     History of Changes
Other Study ID Numbers: 69HCL18_0749
2019-A00684-53 ( Other Identifier: ID RDB )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hashimoto Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroiditis, Autoimmune
Thyroid Diseases
Endocrine System Diseases