An observational study in Healthy, sponsored by Association de Recherche Bibliographique pour les Neurosciences. Completed at 1 site in Monaco. Open to participants aged 15 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by Association de Recherche Bibliographique pour les Neurosciences · Observational
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.
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.
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).
Exclusion Criteria:
Subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.
Other: eVOG (Mobile VideoOculoGraphy)
Subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment.
Other: 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)
Oculomotor profiles concordance
Analyze of the concordance of the profiles obtained between the e-VOG digital assessment and the standard video-oculography assessment. Evaluation criteria: For each assessment, patients will be classified according to the number of oculomotor abnormality observed (based on identified parameters assessments: latency / speed / gain / altered ocular pursuits / fixation disorders / presence of internuclear ophthalmoplegia), in accordance with the literature standards.
Time frame: Day 0
Latency during horizontal reflex saccades
Measure of Latency during an horizontal reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: latency (reaction time in ms).
Time frame: Day 0
Latency during vertical reflex saccades
Measure of Latency during a vertical reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: latency (reaction time in ms).
Time frame: Day 0
Latency during horizontal voluntary saccades
Measure of Latency during an horizontal volontary saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: latency (reaction time in ms).
Time frame: Day 0
Velocity during horizontal reflex saccades
Measure of Velocity during an horizontal reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: velocity (mean and peak velocity) in °/s.
Time frame: Day 0
Velocity during vertical reflex saccades
Measure of Velocity during a vertical reflex saccades paradigm with e-VOG Compared to the one performed with standard video-oculography device. Evaluation criteria: velocity (mean and peak velocity) in °/s.
Time frame: Day 0
Inhibition capacity
Measure of inhibition capacity performance during an antisaccades" paradigm with e-VOG Compared to the one evaluated with standard video-oculography device. Evaluation criteria: percentage of errors.
Time frame: Day 0
Internuclear ophthalmoplegia (INO) detection
Highlight presence/absence of INO with e-VOG Compared to standard video-oculography device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is \>1.
Time frame: Day 0
Fixations impairments detection
Highlight presence/absence of Fixations impairments with e-VOG Compared to standard video-oculography device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters.
Time frame: Day 0
Impairment of horizontal smooth pursuit
Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device. Evaluation criteria: presence/absence of saccade and perturbation.
Time frame: Day 0
Impairment of vertical smooth pursuit
Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device. Evaluation criteria: presence/absence of saccade and perturbation.
Time frame: Day 0
Plan to share: No
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Association de Recherche Bibliographique pour les Neurosciences