Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography and Correlation to Imaging Data in Young Athletes

NCT ID: NCT05385601

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-06-08

Brief Summary

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on smartphones or tablets, to record eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in young athletes. This study also aims to correlate these measurements with volumetric data from cerebral imaging (if MRI done in routine care at the same period, more or less 1 month).

Detailed Description

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.

In the continuity of the e-VOG(YA) study (NCT05211752), we set-up study named e-VOG-Young Athletes-Extension. This study will increase the number of assessments carried out (standard video-oculography assessment versus e-VOG digital assessment) in a population of athletes without major health problems, and who have not presented concussion, in order to meet more powerfully the main objective of the e-VOG(YA) study. It will also make it possible to observe whether there is a correlation between disturbed oculomotor movements, oculomotor anomalies and volumetric data measured by cerebral MRI (obtained using automatic segmentation software on cerebral regions specifically involved in the eye movement control).

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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 developed on an iPad, 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 developed on an iPad, 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

eVOG (Mobile VideoOculoGraphy)

• Eyes movements assessed with e-VOG (mobile application developed on an iPad, 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

Inclusion Criteria

• Young Athletes from AS Monaco 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.

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: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

Responsibility Role: SPONSOR

Principal Investigators

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, MD-PHD

Role: STUDY_DIRECTOR

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

Locations

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

Monaco, , Monaco

Countries

Monaco

Other Identifiers

e-VOG-Young Athletes-Extension

Identifier Type: -

Identifier Source: org_study_id