Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography in Young Athletes (e-VOG(YA))

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: eVOG (Mobile VideoOculoGraphy)

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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Monaco
  • Monaco, Monaco, 98000
    • Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy young athletes (Eye-Tracker®T2 + e-VOG); Subjects who first perform standard video-oculography assessment, followed by e-VOG digital 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)
Healthy young athletes (e-VOG + Eye-Tracker®T2); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	Day 0

Collaborators and Investigators

• Sponsor: Association de Recherche Bibliographique pour les Neurosciences
• Collaborators: Centre Hospitalier Universitaire de Nice; Centre Hospitalier Princesse Grace; Association Sportive Monaco Football Club
• Investigators: Principal Investigator: Mikael COHEN, MD, Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France; Principal Investigator: Sandrine LOUCHART DE LA CHAPELLE, MD-PHD, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco; Study Director: Alain PESCE, PUPH, Association de Recherche Bibliographique pour les Neurosciences; Principal Investigator: Sylvain BLANCHARD, MD-PHD, Association Sportive Monaco Football Club

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Young Athletes
• Other Study ID Numbers: e-VOG Young Athletes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No