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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702763
• Other study ID #: e-VOG
• Status: Completed
• Start date: October 8, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2022
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Eye-Tracker®T2 + e-VOG
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
• e-VOG + Eye-Tracker®T2
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

Locations

Country	Name	City	State
Monaco	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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