Clinical trial NCT04702763: Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography in Patients With Multiple Sclerosis
Official title: Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography Data in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Demyelinating disease
Multiple Sclerosis
Video-oculography
Eye-Tracking
Eye movements
Subclinical oculomotor abnormalities
Oculomotor disorders
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
name: Centre Hospitalier Universitaire de Nice
First posted: 2021-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients with MS for whom a standard video-oculography exam is prescribed by the CRC SEP of the CHU de Nice (France) as part of routine care.

Standard video-oculography exam is carried out at the Center Rainier III (Princess Grace Hospital - Monaco), in accordance with usual practices. It is used at the Centre Rainier III since August 2014. It is a non-invasive device for eye movements recording, allowing doctors and researchers to measure standard parameters related to eye movements. Developed by the Eye Brain Company (France), this is a Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE

Brief summary: This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis.

Detailed description: Based on literature, investigators hypothesize that it would be relevant to focus more broadly on subclinical abnormalities of oculomotricity in multiple sclerosis (MS). However, the difficulty of accessing video-oculography platforms (or eye-tracking devices) is probably one of the main limitations to performing this type of assessment.

To respond this problem, the "Resources and Skills Center-Multiple Sclerosis" (CRC SEP) team at the Nice University Hospital Center (France) has developed a mobile application (named e-VOG), usable on mobile phones or tablets, to measure eye movements. e-VOG reproduces the classic paradigms of video-oculography to collect data similar to standard video-oculography recording (saccade latency and speed, anti-saccade error rate, presence of fixation abnormalities).

e-VOG will not replace standard video-oculography platforms, because its technical characteristics are not as high. But investigators hypothesize that this application could constitute a screening tool for subclinical oculomotor abnormalities, usable by neurologists in consultation, directly on their mobile, which would make it possible to select a smaller population of patients in whom a further exploration by standard video-oculography would be indicated.

Memory Center of the Rainier III Gerontologic Center (Princess Grace Hospital - Monaco) is equipped with a standard video-oculography device, also named eye-tracking device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).

This study is a collaborative study between the Center Rainier III team and the CRC SEP team in Nice. Its objective will be to compare measurements obtained through the e-VOG application with measurements from the standard video-oculography device.

Eligibility criteria: Inclusion Criteria:

* Male or Female.
* 18 years old and above.
* referred by a neurologist to perform a video-oculography (Eye-Tracking) examination as part of routine care.
* with Multiple Sclerosis (defined according to McDonald's 2017 criteria).
* covered by a health insurance system
* volunteer, able to give free, informed and written consent.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination.
* Oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.

Primary outcomes:
measure: Oculomotor profiles concordance
timeFrame: Day 0
Secondary outcomes:
measure: Latency during horizontal reflex saccades
timeFrame: Day 0
measure: Latency during vertical reflex saccades
timeFrame: Day 0
measure: Velocity during horizontal reflex saccades
timeFrame: Day 0
measure: Velocity during vertical reflex saccades
timeFrame: Day 0
measure: Inhibition capacity
timeFrame: Day 0
measure: Internuclear ophthalmoplegia (INO) detection
timeFrame: Day 0
measure: Fixations impairments detection
timeFrame: Day 0
measure: Impairment of horizontal smooth pursuit
timeFrame: Day 0
measure: Impairment of vertical smooth pursuit
timeFrame: Day 0
measure: Patient acceptability of the e-VOG digital assessment
timeFrame: Day 0
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Study officials:
affiliation: Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
name: Mikael COHEN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
name: Christine LEBRUN-FRENAY, PUPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
name: Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
name: Alain PESCE, PUPH
role: STUDY_DIRECTOR
References: