HealthyNCT05385601

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

An observational study of Healthy, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: eVOG (Mobile VideoOculoGraphy)
How many people: 36 participants
Where: 1 siteMonaco
Study dates: 17 May 2022to 8 Jun 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 19 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.

Who may be able to join

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.

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

Other trials in Monaco

About this study

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).

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 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)

Study groups in NCT05385601
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 (17)

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
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).
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 20228 Jun 2022

First posted23 May 2022
Study start17 May 2022
Primary completion8 Jun 2022
Study completion8 Jun 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05385601
Sponsor's protocol ID: e-VOG-Young Athletes-Extension
Status last verified: Jul 2022
First submitted: 18 May 2022
Last updated: 20 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 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 and Correlation to Imaging Data in Young Athletes
ClinicalTrials.gov ID: NCT05385601
Acronym / sponsor ID: e-VOG-Young Athletes-Extension
Conditions: Healthy
Keywords: Young athletes
Study type: Observational
Recruitment status: Completed
Enrolment: 36 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: 17 May 2022 (actual)
Primary completion: 8 Jun 2022 (actual)
Study completion: 8 Jun 2022 (actual)
First posted: 23 May 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.

Detailed description

e-VOG is a mobile application, home-developed by the Neurology Department team of Nice University Hospital, to measure eye movements.

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 19 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.

Key inclusion criteria (4 listed)

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.

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 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)	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

17 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
Imaging data correlation: Total brain volume
Time frame: Day 0
Imaging data correlation: Frontal Lobe Volume
Time frame: Day 0
Imaging data correlation: Parietal Lobe Volume
Time frame: Day 0
Imaging data correlation: Volume of additional motor areas
Time frame: Day 0
Imaging data correlation: Basal ganglia volume
Time frame: Day 0
Imaging data correlation: Total thalamic volume
Time frame: Day 0
Imaging data correlation: cerebellar volume
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 20 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Healthy

RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers

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, MD-PHD study director

AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)

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 4 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 20 Jul 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?

On the ClinicalTrials.gov record for NCT05385601.

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 20 Jul 2022.