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 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.
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 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).
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).
Association de Recherche Bibliographique pour les Neurosciences is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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)
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
Imaging data correlation: Total brain volume
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Total brain volume (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Imaging data correlation: Frontal Lobe Volume
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Frontal Lobe Volume (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Imaging data correlation: Parietal Lobe Volume
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Parietal Lobe Volume (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Imaging data correlation: Volume of additional motor areas
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Volume of additional motor areas (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Imaging data correlation: Basal ganglia volume
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Basal ganglia volume (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Imaging data correlation: Total thalamic volume
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Total thalamic volume (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Imaging data correlation: cerebellar volume
Analyze if there are correlation between oculomotor abnormalities and volumetric data measured by brain MRI. Evaluation criteria: Cerebellar volume (Data from cerebellar MRI performed in routine care, obtained using automatic segmentation software).
Time frame: Day 0
Plan to share: No
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Ran from May 2022 to primary completion in Jun 2022, 0 months.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Association de Recherche Bibliographique pour les Neurosciences