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Multiple SclerosisDIVEyesNCT05776511

Diagnostic Value of eVOG

A study testing eVOG in people with Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Eye movement is a complex neurological function controlled by many structures located in the central nervous system. The eyeball is mobile within the orbit and its movements are carried out using 6 muscles innervated by 3 oculomotor nerves allowing to perform reflex or voluntary eye movements in all elementary… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
eVOG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
7 Apr 2023to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Presence of a neurological, ophthalmological or general pathology that may interfere with the performance of digital video oculography

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mikael COHEN contact

33492038252

cohen.m@chu-nice.fr

Cassandre LANDES CHATEAU contact

33492034126

landes.c@chu-nice.fr

France1 site, 1 recruiting
  • Nice University Hospital

    Nice, 06000

    Cassandre LANDES-CHATEAU, 33492034126, landes.c@chu-nice.fr

    mikael COHEN

    Recruiting

Other trials in France

About this study

Official title: Diagnostic Value of Digital Video Oculography in Patients With White Matter Lesions

Eye movement is a complex neurological function controlled by many structures located in the central nervous system. The eyeball is mobile within the orbit and its movements are carried out using 6 muscles innervated by 3 oculomotor nerves allowing to perform reflex or voluntary eye movements in all elementary directions.

So-called internuclear structures allow the two eyeballs to perform combined movements. The attack of these structures during an acute or chronic neurological disease will most often cause oculomotor paralysis in one or more directions of gaze which will be perceived by the patient as double vision.

Read more

So-called supranuclear structures make it possible to generate different types of eye movements: saccades, which are extremely rapid eye movements of very short duration, eye pursuit, which is a slow movement whose purpose is to follow a moving visual target and finally, certain neural circuits are intended to stabilize the gaze.

Many neurological diseases can be accompanied by oculomotor abnormalities affecting saccades or ocular pursuit. These include neurodegenerative diseases characterized by diffuse neurological damage.

Involvement of gaze stabilization structures is also frequently found in certain neurological diseases affecting the posterior fossa.

The clinical examination of oculomotricity focuses mainly on the analysis of ocular mobility in the different directions of space by asking the subject to fix an object (for example a pen) or the index of the examiner in moving in different directions in space. During a classic clinical examination, it is then possible to detect anomalies such as oculomotor paralysis or nystagmus, it is however very difficult to assess the speed or the precision of the saccades, as well as the quality of the pursuit ocular.

As a result, the development of techniques to accurately record eye movements has emerged as a need in order to help in the diagnosis of certain visual disorders and certain neurodegenerative diseases.

Video oculography (VOG) is a technique for precisely recording and analyzing the movements of the eyeballs.

The use of VOG in neurology has long been dominated by helping to diagnose certain neurodegenerative diseases and in particular certain atypical Parkinson's syndromes. The value of VOG has also been demonstrated in certain pathologies characterized by atrophy of the brainstem or cerebellum, of hereditary or acquired origin. Some studies have also assessed its contribution to the diagnosis and management of certain dementias and certain psychiatric diseases such as schizophrenia. More recently, the interest of VOG has also emerged in the management of patients with a demyelinating disease of the multiple sclerosis spectrum.

The VOG has a number of limitations to its large-scale use, first of all, it is an examination requiring specific, relatively expensive equipment. On the other hand, the examination requires know-how, both for the passing of the tests but also for the processing and analysis of the data.

The eVOG (mobile VideoOculoGraphy) application has been developed to record oculomotor movements during different paradigms: horizontal saccades, vertical saccades, antisaccades, horizontal pursuit, vertical pursuit thanks to a tablet fixed on a support allowing keep in a stable and fixed position.

The eVOG app was compared to a conventional VOG platform in a first study. The objective was to compare the measurements obtained by the eVOG application to the measurements collected by the standard method in a sample of patients with multiple sclerosis. This study showed that the detection of different anomalies by eVOG is correlated with classic VOG.

In view of these encouraging preliminary results, a prospective study could be set up with the objective of evaluating the value of digital VOG in the diagnostic process in patients referred to a tertiary center for white matter signal abnormalities on MRI.

the hypothesis is that subclinical oculomotor disorders will be found more frequently in the group of patients with MS spectrum disease due to the presence in this pathology of diffuse inflammatory and degenerative damage to brain tissue, unlike the others inflammatory or non-inflammatory pathologies.

Being tested
eVOG
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eVOGProcedure or surgery

    video digital oculography

Study groups in NCT05776511
Study groupRoleWhat they receive
suggestive demyelinating diseaseOtherWhite matter lesions suggestive demyelinating diseases
Receives: Procedure: eVOG
no suggestive demyelinating diseasesOtherWhite matter lesions not suggestive demyelinating diseases
Receives: Procedure: eVOG
ControlsOtherpatients controls
Receives: Procedure: eVOG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions. (square wave jerks)

    The interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA):

    • Presence of square wave jerks 0 or 1

    Measured: day of inclusion

  2. interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions. (Horizontal saccades abnormalities)

    The interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA):

    • Presence of Horizontal saccades abnormalities 0 or 1

    Measured: day of inclusion

  3. interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions. (Vertical saccades abnormalities)

    The interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA):

    • Presence of Vertical saccades abnormalities 0 or 1

    Measured: day of inclusion

  4. interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions. (Smooth pursuit abnormality)

    The interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA):

    • Presence of Smooth pursuit abnormality 0 or 1

    Measured: day of inclusion

  5. interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions. (Antisaccade abnormality)

    The interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA):

    • Antisaccade abnormality 0 or 1

    Measured: day of inclusion

  6. interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions

    score (0 to 5) of he interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA)

    Measured: day of inclusion

Secondary outcomes (6)
  1. Correlations between the presence of EMA and the diffuse damage to brain tissue measured by MRI.(In the subgroup of patients with RIS, CIS or MS, to study)

    Global and regional volumetric measurements

    Measured: day of inclusion

  2. association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (EDSS)

    EDSS score

    Measured: each year to 2 years

  3. association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (second line treatment)

    Evolution towards an active form requiring the use of a second-line treatment (natalizumab, ocrelizumab, fingolimod, cladribine)

    Measured: at year 1 and year 2

  4. association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (secondary progressive form)

    Evolution towards a secondary progressive form (clinically)

    Measured: at year 1 and year 2

  5. type of EMA between patients and controls

    type of EMA

    Measured: day of inclusion

  6. number of EMA between patients and controls

    Number of EMA

    Measured: day of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start7 Apr 2023
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776511
Sponsor's protocol ID
22-PP-08
Acronym
DIVEyes
Status last verified
Jun 2026
First submitted
8 Mar 2023
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing eVOG in people with Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice 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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mikael COHEN (33492038252, cohen.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions. (square wave jerks) (time frame: day of inclusion). The study lists 6 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 16 Jun 2026.

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Diagnostic Value of eVOG (NCT05776511) | AzTrials