Clinical trial NCT05385601: Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography and Correlation to Imaging Data in Young Athletes
Official title: Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography and Correlation to Imaging Data in Young Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Young athletes
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
name: Centre Hospitalier Universitaire de Nice
name: Association Sportive Monaco Football Club
First posted: 2022-05-23
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young athletes for whom a standard video-oculography exam is prescribed by the AS Monaco Football medical Team as part of a preventive and follow-up approach performed in routine care.

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).

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.

Primary outcomes:
measure: Oculomotor profiles concordance
timeFrame: Day 0
Secondary outcomes:
measure: Latency during horizontal reflex saccades
timeFrame: Day 0
measure: Latency during vertical reflex saccades
timeFrame: Day 0
measure: Latency during horizontal voluntary saccades
timeFrame: Day 0
measure: Velocity during horizontal reflex saccades
timeFrame: Day 0
measure: Velocity during vertical reflex saccades
timeFrame: Day 0
measure: Inhibition capacity
timeFrame: Day 0
measure: Internuclear ophthalmoplegia (INO) detection
timeFrame: Day 0
measure: Fixations impairments detection
timeFrame: Day 0
measure: Impairment of horizontal smooth pursuit
timeFrame: Day 0
measure: Impairment of vertical smooth pursuit
timeFrame: Day 0
measure: Imaging data correlation: Total brain volume
timeFrame: Day 0
measure: Imaging data correlation: Frontal Lobe Volume
timeFrame: Day 0
measure: Imaging data correlation: Parietal Lobe Volume
timeFrame: Day 0
measure: Imaging data correlation: Volume of additional motor areas
timeFrame: Day 0
measure: Imaging data correlation: Basal ganglia volume
timeFrame: Day 0
measure: Imaging data correlation: Total thalamic volume
timeFrame: Day 0
measure: Imaging data correlation: cerebellar volume
timeFrame: Day 0
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Study officials:
affiliation: Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
name: Mikael COHEN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
name: Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
name: Alain PESCE, MD-PHD
role: STUDY_DIRECTOR
References: