Healthye-VOG(YA)NCT05211752
Eye Movements Recording Using a Mobile : Comparison to Standard Video-oculography in Young Athletes
An observational study of Healthy, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
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. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- eVOG (Mobile VideoOculoGraphy)
- How many people
- 46 participants
- Where
- 1 siteMonaco
- Study dates
- 18 Jan 2022to 22 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Monaco1 site
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, 98000
About this study
Official title: 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.
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.
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.
- Conditions
- Healthy
- Being tested
- eVOG (Mobile VideoOculoGraphy)
- Keywords
- Young Athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Healthy young athletes (Eye-Tracker®T2 + e-VOG) | Subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment. Receives: 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. Receives: Other: eVOG (Mobile VideoOculoGraphy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start18 Jan 2022
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice, Association Sportive Monaco Football Club
- Responsible party
- Sponsor
- Investigators
- Mikael COHEN, MD, Principal investigator, Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-FranceSandrine LOUCHART de la CHAPELLE, MD-PHD, Principal investigator, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, MonacoAlain PESCE, PUPH, Study director, Association de Recherche Bibliographique pour les NeurosciencesSylvain BLANCHARD, MD-PHD, Principal investigator, Association Sportive Monaco Football Club
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211752
- Sponsor's protocol ID
- e-VOG Young Athletes
- Acronym
- e-VOG(YA)
- Status last verified
- May 2022
- First submitted
- 14 Jan 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography Data in Young Athletes
- ClinicalTrials.gov ID
- NCT05211752
- Acronym / sponsor ID
- e-VOG(YA) / e-VOG Young Athletes
- Conditions
- Healthy
- Keywords
- Young Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice, Association Sportive Monaco Football Club
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy young athletes (Eye-Tracker®T2 + e-VOG) | – | Other: eVOG (Mobile VideoOculoGraphy)Subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment. |
| Healthy young athletes (e-VOG + Eye-Tracker®T2) | – | Other: eVOG (Mobile VideoOculoGraphy)Subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Healthy young athletes (Eye-Tracker®T2 + e-VOG), Healthy young athletes (e-VOG + Eye-Tracker®T2) |
Primary outcome
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.
10 secondary outcomes
Latency during horizontal reflex saccades
Time frame: Day 0
Latency during vertical reflex saccades
Time frame: Day 0
Latency during horizontal voluntary saccades
Time frame: Day 0
Velocity during horizontal reflex saccades
Time frame: Day 0
Velocity during vertical reflex saccades
Time frame: Day 0
Inhibition capacity
Time frame: Day 0
Internuclear ophthalmoplegia (INO) detection
Time frame: Day 0
Fixations impairments detection
Time frame: Day 0
Impairment of horizontal smooth pursuit
Time frame: Day 0
Impairment of vertical smooth pursuit
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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, PUPH study director
Association de Recherche Bibliographique pour les Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oculomotor profiles concordance (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 2 Nov 2026.