search
Back to results

Diagnostic Value of eVOG (DIVEyes)

Primary Purpose

Multiple Sclerosis, Radiologically Isolated Syndrome, White Matter Lesions

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
eVOG
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patients Inclusion Criteria: 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 controls Inclusion criteria: 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 Exclusion Criteria: Presence of a neurological, ophthalmological or general pathology that may interfere with the performance of digital video oculography

Sites / Locations

  • Nice University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

suggestive demyelinating disease

no suggestive demyelinating diseases

Controls

Arm Description

White matter lesions suggestive demyelinating diseases

White matter lesions not suggestive demyelinating diseases

patients controls

Outcomes

Primary Outcome Measures

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
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
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
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
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
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)

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2023
Last Updated
May 4, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT05776511
Brief Title
Diagnostic Value of eVOG
Acronym
DIVEyes
Official Title
Diagnostic Value of Digital Video Oculography in Patients With White Matter Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Radiologically Isolated Syndrome, White Matter Lesions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
suggestive demyelinating disease
Arm Type
Other
Arm Description
White matter lesions suggestive demyelinating diseases
Arm Title
no suggestive demyelinating diseases
Arm Type
Other
Arm Description
White matter lesions not suggestive demyelinating diseases
Arm Title
Controls
Arm Type
Other
Arm Description
patients controls
Intervention Type
Procedure
Intervention Name(s)
eVOG
Intervention Description
video digital oculography
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
day of inclusion
Title
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)
Description
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
Time Frame
day of inclusion
Title
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)
Description
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
Time Frame
day of inclusion
Title
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)
Description
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
Time Frame
day of inclusion
Title
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)
Description
The interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA): - Antisaccade abnormality 0 or 1
Time Frame
day of inclusion
Title
interest of digital VOG at the diagnostic stage in patients referred to a tertiary center for discovery on MRI of white matter lesions
Description
score (0 to 5) of he interpretation of the VOG will reveal the presence or absence of the following eye movement abnormalities (EMA)
Time Frame
day of inclusion
Secondary Outcome Measure Information:
Title
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)
Description
Global and regional volumetric measurements
Time Frame
day of inclusion
Title
association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (EDSS)
Description
EDSS score
Time Frame
each year to 2 years
Title
association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (second line treatment)
Description
Evolution towards an active form requiring the use of a second-line treatment (natalizumab, ocrelizumab, fingolimod, cladribine)
Time Frame
at year 1 and year 2
Title
association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (secondary progressive form)
Description
Evolution towards a secondary progressive form (clinically)
Time Frame
at year 1 and year 2
Title
type of EMA between patients and controls
Description
type of EMA
Time Frame
day of inclusion
Title
number of EMA between patients and controls
Description
Number of EMA
Time Frame
day of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients Inclusion Criteria: 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 controls Inclusion criteria: 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 Exclusion Criteria: Presence of a neurological, ophthalmological or general pathology that may interfere with the performance of digital video oculography
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael COHEN
Phone
33492038252
Email
cohen.m@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandre LANDES CHATEAU
Phone
33492034126
Email
landes.c@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandre LANDES-CHATEAU
Phone
33492034126
Email
landes.c@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
mikael COHEN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diagnostic Value of eVOG

We'll reach out to this number within 24 hrs