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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Eye-Tracker®T2 + e-VOG; Other: e-VOG + Eye-Tracker®T2

• Registration Number: NCT04702763
• Lead Sponsor: Association de Recherche Bibliographique pour les Neurosciences

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.

Study Timeline

• Study Start: 2020-10-08
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis (Eye-Tracker®T2 + e-VOG)	Eye-Tracker®T2 + e-VOG	Multiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.
Multiple Sclerosis (e-VOG + Eye-Tracker®T2)	e-VOG + Eye-Tracker®T2	Multiple Sclerosis subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment.

Primary Outcome Measures

Name	Time	Method
Oculomotor profiles concordance	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Latency during horizontal reflex saccades	Day 0	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).
Velocity during horizontal reflex saccades	Day 0	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.
Internuclear ophthalmoplegia (INO) detection	Day 0	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.
Patient acceptability of the e-VOG digital assessment	Day 0	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.
Latency during vertical reflex saccades	Day 0	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).
Inhibition capacity	Day 0	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.
Velocity during vertical reflex saccades	Day 0	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.
Impairment of horizontal smooth pursuit	Day 0	Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device.; Evaluation criteria: presence/absence of saccade and perturbation.
Fixations impairments detection	Day 0	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.
Impairment of vertical smooth pursuit	Day 0	Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device.; Evaluation criteria: presence/absence of saccade and perturbation.

Trial Locations

Locations (1)

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital; 🇲🇨 Monaco, Monaco