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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385601
• Other study ID #: e-VOG-Young Athletes-Extension
• Status: Completed
• Start date: May 17, 2022
• Est. completion date: June 8, 2022

Study information

• Verified date: July 2022
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Monaco	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco

Sponsors (4)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Association Sportive Monaco Football Club, Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0