Clinical trial NCT05211752: Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography in Young Athletes
Official title: Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography 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: 2022-01-27
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
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.

Eye-tracking is a relevant and essential assessment for the detection and monitoring of neuro-cognitive alterations in young athletes which may result from macro-trauma (concussion) or repeated micro-trauma (head game) occurring during the season.

Standard video-oculography exam is carried out at the Center Rainier III (Princess Grace Hospital), in accordance with usual practices. It is a non-invasive device for eye movements recording, allowing doctors to measure standard parameters related to eye movements (Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE).

Brief summary: 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: 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.

Eligibility criteria: 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.

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
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: Association de Recherche Bibliographique pour les Neurosciences
name: Alain PESCE, PUPH
role: STUDY_DIRECTOR
affiliation: Association Sportive Monaco Football Club
name: Sylvain BLANCHARD, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: