Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography in Young Athletes

NCT ID: NCT05211752

Last Updated: 2022-05-18

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

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2022-02-22

Brief Summary

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This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on smartphones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in young athletes.

Detailed Description

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e-VOG Young athletes is a collaborative study between the Memory Center of the Rainier III Center (Princess Grace Hospital, Monaco), the Neurology Department of Nice University Hospital (France), and the AS Monaco Football Academy medical team.

Memory Center of the Rainier III Center is expert in eye-tracking and is equipped with a standard video-oculography device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).

e-VOG is a mobile application, home-developed by the Neurology Department team of Nice University Hospital, to measure eye movements.

Based on literature, investigators hypothesize that video-oculography could integrate assessment protocols for head trauma occurring during sports practice. The nomadic nature of the e-VOG application would make possible to assess oculomotor behaviors to a subject who has just suffered a trauma and who is suspected of having a concussion.

From this perspective, it seems necessary to firstly validate baseline values of the e-VOG application in a population of athletes without major health problems, and who have not presented concussion.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy young athletes (Eye-Tracker®T2 + e-VOG)

Subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.

eVOG (Mobile VideoOculoGraphy)

Intervention Type OTHER

* Eyes movements assessed with e-VOG (mobile application, that uses the face detection features of the front camera to detect and record eye movements).
* Study duration is about 20 minutes, the day the subject performs his standard video-oculography examination in routine care (using Eye-Tracker®T2)

Healthy young athletes (e-VOG + Eye-Tracker®T2)

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

eVOG (Mobile VideoOculoGraphy)

Intervention Type OTHER

* Eyes movements assessed with e-VOG (mobile application, that uses the face detection features of the front camera to detect and record eye movements).
* Study duration is about 20 minutes, the day the subject performs his standard video-oculography examination in routine care (using Eye-Tracker®T2)

Interventions

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eVOG (Mobile VideoOculoGraphy)

* Eyes movements assessed with e-VOG (mobile application, that uses the face detection features of the front camera to detect and record eye movements).
* Study duration is about 20 minutes, the day the subject performs his standard video-oculography examination in routine care (using Eye-Tracker®T2)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Young Athletes from AS Monaco Football Academy
* referred by AS Monaco Medical Team to perform a video-oculography (Eye-Tracking) examination as part of routine care.
* covered by a health insurance system
* volunteer, able to give free, informed and written consent.
* For minors: whose holder of parental authority has given their written consent to participate following the information given by investigator.

Exclusion Criteria

* General anaesthesia within 3 months.
* Head trauma 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

15 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Princesse Grace

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

Association Sportive Monaco Football Club

UNKNOWN

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

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

Association de Recherche Bibliographique pour les Neurosciences

Sylvain BLANCHARD, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Association Sportive Monaco Football Club

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 Young Athletes

Identifier Type: -

Identifier Source: org_study_id

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