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

NCT ID: NCT04702763

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-10-30

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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Multiple Sclerosis (Eye-Tracker®T2 + e-VOG)

Multiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.

Eye-Tracker®T2 + e-VOG

Intervention Type OTHER

* 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

Multiple Sclerosis (e-VOG + Eye-Tracker®T2)

Multiple Sclerosis subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment.

e-VOG + Eye-Tracker®T2

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Princesse Grace

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

Association de Recherche Bibliographique pour les Neurosciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikael COHEN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France

Christine LEBRUN-FRENAY, PUPH

Role: PRINCIPAL_INVESTIGATOR

Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France

Sandrine LOUCHART DE LA CHAPELLE, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco

Alain PESCE, PUPH

Role: STUDY_DIRECTOR

AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)

Locations

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Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, , Monaco

Site Status

Countries

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Monaco

Other Identifiers

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e-VOG

Identifier Type: -

Identifier Source: org_study_id

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