Multiple Sclerosis Clinical Trial
— DIVEyesOfficial title:
Diagnostic Value of Digital Video Oculography in Patients With White Matter Lesions
NCT number | NCT05776511 |
Other study ID # | 22-PP-08 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 7, 2023 |
Est. completion date | April 1, 2026 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Nice University Hospital | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | day of inclusion | |
Secondary | association between the number or type of EMA at inclusion and the occurrence of a clinical conversion to multiple sclerosis (EDSS) | EDSS score | each year to 2 years | |
Secondary | 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) | at year 1 and year 2 | |
Secondary | 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) | at year 1 and year 2 | |
Secondary | type of EMA between patients and controls | type of EMA | day of inclusion | |
Secondary | number of EMA between patients and controls | Number of EMA | day of inclusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|