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Completed

NCT Number: NCT05385601

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

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).

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Key information

Conditions

Healthy

Age range

15 year–19 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.

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).

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 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.

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 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)

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.

  11. Imaging data correlation: Total brain volume

    Time frame: Day 0

    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).

  12. Imaging data correlation: Frontal Lobe Volume

    Time frame: Day 0

    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).

  13. Imaging data correlation: Parietal Lobe Volume

    Time frame: Day 0

    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).

  14. Imaging data correlation: Volume of additional motor areas

    Time frame: Day 0

    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).

  15. Imaging data correlation: Basal ganglia volume

    Time frame: Day 0

    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).

  16. Imaging data correlation: Total thalamic volume

    Time frame: Day 0

    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).

  17. Imaging data correlation: cerebellar volume

    Time frame: Day 0

    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).

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 23, 2022
Registry last updated
Jul 20, 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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