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CompletedNCT05385601Updated Jul 20, 2022

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

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

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
36
Ages
15 Years to 19 Years
Sex
All
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Study summary

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).

Read the 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.

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).

02

Conditions studied

  • Healthy

Keywords

  • Young athletes
03

In context

Lead sponsor

Association de Recherche Bibliographique pour les Neurosciences is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

Interventions

  • OthereVOG (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)

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

07

Study locations

1 site
  • Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
    Monaco, 98000, Monaco
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Jun 2022, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2022
First posted
May 23, 2022
StartActual
May 17, 2022
Primary completionActual
Jun 8, 2022
CompletionActual
Jun 8, 2022
Last update
Jul 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05385601
Lead sponsor
Association de Recherche Bibliographique pour les Neurosciences
Collaborators
Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice, Association Sportive Monaco Football Club
Responsible party
Sponsor
First posted
May 23, 2022
Start date
May 17, 2022
Primary completion
Jun 8, 2022
Completion
Jun 8, 2022
Last update
Jul 20, 2022

Study contacts

Mikael COHEN, MD
principal investigator · Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
principal investigator · Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
Alain PESCE, MD-PHD
study director · AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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