An observational study in Multiple Sclerosis, sponsored by Association de Recherche Bibliographique pour les Neurosciences. Completed at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Association de Recherche Bibliographique pour les Neurosciences · Observational
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Association de Recherche Bibliographique pour les Neurosciences is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Multiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.
Other: Eye-Tracker®T2 + e-VOG
Multiple Sclerosis subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment.
Other: e-VOG + Eye-Tracker®T2
* 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
* 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
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.
Time frame: Day 0
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0
Plan to share: No
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Association de Recherche Bibliographique pour les Neurosciences