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Completed

NCT Number: NCT05211752

Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography 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.

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Key information

Conditions

Healthy

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eVOG (Mobile VideoOculoGraphy)

Other
  • 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)

Primary outcomes

  1. Oculomotor profiles concordance

    Time frame: Day 0

    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.

Secondary outcomes

  1. Latency during horizontal reflex saccades

    Time frame: Day 0

    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).

  2. Latency during vertical reflex saccades

    Time frame: Day 0

    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).

  3. Latency during horizontal voluntary saccades

    Time frame: Day 0

    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).

  4. Velocity during horizontal reflex saccades

    Time frame: Day 0

    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.

  5. Velocity during vertical reflex saccades

    Time frame: Day 0

    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.

  6. Inhibition capacity

    Time frame: Day 0

    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.

  7. Internuclear ophthalmoplegia (INO) detection

    Time frame: Day 0

    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.

  8. Fixations impairments detection

    Time frame: Day 0

    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.

  9. Impairment of horizontal smooth pursuit

    Time frame: Day 0

    Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device.

    Evaluation criteria: presence/absence of saccade and perturbation.

  10. Impairment of vertical smooth pursuit

    Time frame: Day 0

    Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device.

    Evaluation criteria: presence/absence of saccade and perturbation.

Sponsors and collaborators

Lead sponsor

Association de Recherche Bibliographique pour les Neurosciences

Other

Collaborators

  • Association Sportive Monaco Football Club
  • Centre Hospitalier Princesse Grace
  • Centre Hospitalier Universitaire de Nice

Registry information

Official study title

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

Acronym: e-VOG(YA)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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