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

Healthy Clinical Trial

— e-VOG(YA)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211752
• Other study ID #: e-VOG Young Athletes
• Status: Completed
• Start date: January 18, 2022
• Est. completion date: February 22, 2022

Study information

• Verified date: May 2022
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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)

Locations

Country	Name	City	State
Monaco	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco

Sponsors (4)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Association Sportive Monaco Football Club, Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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