Autoimmune EncephalitisNODENCT03872284
Neuro-ophthalmology and Autoimmune Encephalitis (NODE)
An observational study of Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- oculomotor movement recordings, neurovisual assessment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2020to 26 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women 18 to 70 years old diagnosed with autoimmune encephalitis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autoimmune Encephalitis
- Being tested
- oculomotor movement recordings, neurovisual assessment
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oculomotor movement recordings, neurovisual assessmentOther
Each participant will have a neurovisual assessment and an oculomotor movement recording with an eye tracker (infra red cameras).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: oculomotor movement recordings, neurovisual assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 6 months if an abnormality is found
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start22 Jan 2020
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Tilikete, Prof., Principal investigator, Department of neuro-ophthalmology, Pierre Wertheimer university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872284
- Sponsor's protocol ID
- 69HCL18_0749
- Other IDs
- 2019-A00684-53
- Acronym
- NODE
- Status last verified
- Jan 2025
- First submitted
- 11 Mar 2019
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)
- ClinicalTrials.gov ID
- NCT03872284
- Acronym / sponsor ID
- NODE / 69HCL18_0749
- Conditions
- Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: oculomotor movement recordings, neurovisual assessmentPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women 18 to 70 years old diagnosed with autoimmune encephalitis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oculomotor movement recordings, neurovisual assessmentEach participant will have a neurovisual assessment and an oculomotor movement recording with an eye tracker (infra red cameras). | Other | 1 |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Tilikete, Prof. principal investigator
Department of neuro-ophthalmology, Pierre Wertheimer university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients presenting a neuro-ophthalmological abnormality. (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.