Diagnostic Value of eVOG

NCT05776511 | Recruiting

• 1 other identifier: 22-PP-08
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

Multiple Sclerosis; Radiologically Isolated Syndrome; White Matter Lesions

Outcome Measures

Primary Outcomes (6)

• 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

  day of inclusion

• 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

  day of inclusion

• 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

  day of inclusion

• 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

  day of inclusion

• 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

  day of inclusion

• 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)

  day of inclusion

Secondary Outcomes (6)

• 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)

  day of inclusion

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

  each year to 2 years

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

  at year 1 and year 2

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

  at year 1 and year 2

• type of EMA between patients and controls

  day of inclusion

Study Arms (3)

suggestive demyelinating disease

OTHER

White matter lesions suggestive demyelinating diseases

Procedure: eVOG

no suggestive demyelinating diseases

OTHER

White matter lesions not suggestive demyelinating diseases

Procedure: eVOG

Controls

OTHER

patients controls

Procedure: eVOG

Interventions

eVOG PROCEDURE

video digital oculography

Controls; no suggestive demyelinating diseases; suggestive demyelinating disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to our tertiary center for a diagnostic workup of white matter hypersignals
• Absence of oculomotor disorders on conventional clinical examination
• Age \> 18 years
• The controls can be recruited from the accompanying persons of the patients selected for the study, from the staff of the CHU of Nice or from the entourage of the investigating team;
• Absence of known oculomotor disorders by the control
• Age \> 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Mikael COHEN

CONTACT

33492038252; cohen.m@chu-nice.fr

Cassandre LANDES CHATEAU

CONTACT

33492034126; landes.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: April 7, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)