Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography Data in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Eye-Tracker®T2 + e-VOG
* Other: e-VOG + Eye-Tracker®T2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis (Eye-Tracker®T2 + e-VOG)<br>Multiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment. | Other: Eye-Tracker®T2 + e-VOG<br>* 1st step: eyes movements assessed with standard video-oculography device 2° step: eyes movements assessed with e-VOG digital application Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care<br>|
| Multiple Sclerosis (e-VOG + Eye-Tracker®T2)<br>Multiple Sclerosis subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment. | Other: e-VOG + Eye-Tracker®T2<br>* 1st step: eyes movements assessed with e-VOG digital application 2° step: eyes movements assessed with standard video-oculography device Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oculomotor profiles concordance | Analyze of the concordance of the profiles obtained between the e-VOG digital assessment and the standard video-oculography assessment. Evaluation criteria: For each assessment, patients will be classified into 3 profiles (Profile 1 = profile without oculomotor abnormality; Profile 2 = intermediate profile with 1 to 2 oculomotor abnormalities; Profile 3: profile with 3 to 4 oculomotor anomalies), based on the observation of 4 parameters (latency / speed / fixation disorders / presence of internuclear ophthalmoplegia), in accordance with the literature standards. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency during horizontal reflex saccades | Measure of Latency during an horizontal reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: latency (reaction time in ms). | Day 0 | 
| Latency during vertical reflex saccades | Measure of Latency during a vertical reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: latency (reaction time in ms). | Day 0 | 
| Velocity during horizontal reflex saccades | Measure of Velocity during an horizontal reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: velocity (mean and peak velocity) in °/s. | Day 0 | 
| Velocity during vertical reflex saccades | Measure of Velocity during a vertical reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: velocity (mean and peak velocity) in °/s. | Day 0 | 
| Inhibition capacity | Measure of inhibition capacity performance during an antisaccades paradigm with e-VOG Compared to the one evaluated with standard video-oculography device. Evaluation criteria: percentage of errors. | Day 0 | 
| Internuclear ophthalmoplegia (INO) detection | Highlight presence/absence of INO with e-VOG Compared to standard video-oculography device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is >1. | Day 0 | 
| Fixations impairments detection | Highlight presence/absence of Fixations impairments with e-VOG Compared to standard video-oculography device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters. | Day 0 | 
| Impairment of horizontal smooth pursuit | Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device. Evaluation criteria: presence/absence of saccade and perturbation. | Day 0 | 
| Impairment of vertical smooth pursuit | Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device. Evaluation criteria: presence/absence of saccade and perturbation. | Day 0 | 
| Patient acceptability of the e-VOG digital assessment | Comparison of patient acceptability between the e-VOG digital assessment and the standard video-oculography assessment. Evaluation criteria: satisfaction questionnaire given to the patient at the end of assessments. 2 questions on the difficulty or discomfort felt during the 2 assessments. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Demyelinating disease, Multiple Sclerosis, Video-oculography, Eye-Tracking, Eye movements, Subclinical oculomotor abnormalities, Oculomotor disorders