Multiple SclerosisNCT04702763
Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, 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 mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Eye-Tracker®T2 + e-VOG and e-VOG + Eye-Tracker®T2
- How many people
- 30 participants
- Where
- 1 siteMonaco
- Study dates
- 8 Oct 2020to 30 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from patients with MS for whom a standard video-oculography exam is prescribed by the CRC SEP of the CHU de Nice (France) as part of routine care. Standard video-oculography exam is carried out at the Center Rainier III (Princess Grace Hospital - Monaco), in accordance with usual practices. It is used at the Centre Rainier III since August 2014. It is a non-invasive device for eye movements recording, allowing doctors and researchers to measure standard parameters related to eye movements. Developed by the Eye Brain Company (France), this is a Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE
Who may be able to join
- Male or Female.
- 18 years old and above.
- referred by a neurologist to perform a video-oculography (Eye-Tracking) examination as part of routine care.
- with Multiple Sclerosis (defined according to McDonald's 2017 criteria).
- covered by a health insurance system
- volunteer, able to give free, informed and written consent.
Who cannot join
- General anaesthesia 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 Patients With Multiple Sclerosis
This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis.
Read the detailed description
Based on literature, investigators hypothesize that it would be relevant to focus more broadly on subclinical abnormalities of oculomotricity in multiple sclerosis (MS). However, the difficulty of accessing video-oculography platforms (or eye-tracking devices) is probably one of the main limitations to performing this type of assessment.
To respond this problem, the "Resources and Skills Center-Multiple Sclerosis" (CRC SEP) team at the Nice University Hospital Center (France) has developed a mobile application (named e-VOG), usable on mobile phones or tablets, to measure eye movements. e-VOG reproduces the classic paradigms of video-oculography to collect data similar to standard video-oculography recording (saccade latency and speed, anti-saccade error rate, presence of fixation abnormalities).
e-VOG will not replace standard video-oculography platforms, because its technical characteristics are not as high. But investigators hypothesize that this application could constitute a screening tool for subclinical oculomotor abnormalities, usable by neurologists in consultation, directly on their mobile, which would make it possible to select a smaller population of patients in whom a further exploration by standard video-oculography would be indicated.
Memory Center of the Rainier III Gerontologic Center (Princess Grace Hospital - Monaco) is equipped with a standard video-oculography device, also named eye-tracking device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).
This study is a collaborative study between the Center Rainier III team and the CRC SEP team in Nice. Its objective will be to compare measurements obtained through the e-VOG application with measurements from the standard video-oculography device.
- Conditions
- Multiple Sclerosis
- Being tested
- Eye-Tracker®T2 + e-VOG, e-VOG + Eye-Tracker®T2
- Keywords
- Demyelinating disease, Multiple Sclerosis, Video-oculography, Eye-Tracking, Eye movements, Subclinical oculomotor abnormalities, Oculomotor disorders
- Medical subject headings
- Multiple Sclerosis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-Tracker®T2 + e-VOGOther
- 1st step: eyes movements assessed with standard video-oculography device
- 2° step: eyes movements assessed with e-VOG digital application
- Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care
e-VOG + Eye-Tracker®T2Other
- 1st step: eyes movements assessed with e-VOG digital application
- 2° step: eyes movements assessed with standard video-oculography device
- Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (Eye-Tracker®T2 + e-VOG) | Multiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment. Receives: Other: Eye-Tracker®T2 + e-VOG | |
| Multiple Sclerosis (e-VOG + Eye-Tracker®T2) | Multiple Sclerosis subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment. Receives: Other: e-VOG + Eye-Tracker®T2 |
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 into 3 profiles (Profile 1 = profile without oculomotor abnormality; Profile 2 = intermediate profile with 1 to 2 oculomotor abnormalities; Profile 3: profile with 3 to 4 oculomotor anomalies), based on the observation of 4 parameters (latency / speed / 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
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
Patient acceptability of the e-VOG digital assessment
Comparison of patient acceptability between the e-VOG digital assessment and the standard video-oculography assessment.
Evaluation criteria: satisfaction questionnaire given to the patient at the end of assessments. 2 questions on the difficulty or discomfort felt during the 2 assessments.
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 posted11 Jan 2021
- Study start8 Oct 2020
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 30 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
- 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-FranceChristine LEBRUN-FRENAY, PUPH, 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, AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702763
- Sponsor's protocol ID
- e-VOG
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2021
- Last updated
- 27 Jan 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 27 Jan 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 Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04702763
- Acronym / sponsor ID
- e-VOG
- Conditions
- Multiple Sclerosis
- Keywords
- Demyelinating disease, Multiple Sclerosis, Video-oculography, Eye-Tracking, Eye movements, Subclinical oculomotor abnormalities, Oculomotor disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 11 Jan 2021 (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 mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis.
Detailed description
Based on literature, investigators hypothesize that it would be relevant to focus more broadly on subclinical abnormalities of oculomotricity in multiple sclerosis (MS). However, the difficulty of accessing video-oculography platforms (or eye-tracking devices) is probably one of the main limitations to performing this type of assessment.
To respond this problem, the "Resources and Skills Center-Multiple Sclerosis" (CRC SEP) team at the Nice University Hospital Center (France) has developed a mobile application (named e-VOG), usable on mobile phones or tablets, to measure eye movements. e-VOG reproduces the classic paradigms of video-oculography to collect data similar to standard video-oculography recording (saccade latency and speed, anti-saccade error rate, presence of fixation abnormalities).
e-VOG will not replace standard video-oculography platforms, because its technical characteristics are not as high. But investigators hypothesize that this application could constitute a screening tool for subclinical oculomotor abnormalities, usable by neurologists in consultation, directly on their mobile, which would make it possible to select a smaller population of patients in whom a further exploration by standard video-oculography would be indicated.
Memory Center of the Rainier III Gerontologic Center (Princess Grace Hospital - Monaco) is equipped with a standard video-oculography device, also named eye-tracking device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).
This study is a collaborative study between the Center Rainier III team and the CRC SEP team in Nice. Its objective will be to compare measurements obtained through the e-VOG application with measurements from the standard video-oculography device.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (Eye-Tracker®T2 + e-VOG) | – | Other: Eye-Tracker®T2 + e-VOGMultiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment. |
| Multiple Sclerosis (e-VOG + Eye-Tracker®T2) | – | Other: e-VOG + Eye-Tracker®T2Multiple Sclerosis subjects who first perform e-VOG digital assessment, followed by the standard video-oculography assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from patients with MS for whom a standard video-oculography exam is prescribed by the CRC SEP of the CHU de Nice (France) as part of routine care. Standard video-oculography exam is carried out at the Center Rainier III (Princess Grace Hospital - Monaco), in accordance with usual practices. It is used at the Centre Rainier III since August 2014. It is a non-invasive device for eye movements recording, allowing doctors and researchers to measure standard parameters related to eye movements. Developed by the Eye Brain Company (France), this is a Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE
Key inclusion criteria (6 listed)
- Male or Female.
- 18 years old and above.
- referred by a neurologist to perform a video-oculography (Eye-Tracking) examination as part of routine care.
- with Multiple Sclerosis (defined according to McDonald's 2017 criteria).
- covered by a health insurance system
Key exclusion criteria (3 listed)
- General anaesthesia 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 |
|---|---|---|
| Eye-Tracker®T2 + e-VOG* 1st step: eyes movements assessed with standard video-oculography device * 2° step: eyes movements assessed with e-VOG digital application * Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care | Other | Multiple Sclerosis (Eye-Tracker®T2 + e-VOG) |
| e-VOG + Eye-Tracker®T2* 1st step: eyes movements assessed with e-VOG digital application * 2° step: eyes movements assessed with standard video-oculography device * Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care | Other | Multiple Sclerosis (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 into 3 profiles (Profile 1 = profile without oculomotor abnormality; Profile 2 = intermediate profile with 1 to 2 oculomotor abnormalities; Profile 3: profile with 3 to 4 oculomotor anomalies), based on the observation of 4 parameters (latency / speed / 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
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
Patient acceptability of the e-VOG digital assessment
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 27 Jan 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
Christine LEBRUN-FRENAY, PUPH 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
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 Multiple Sclerosis, 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 6 inclusion and 3 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 27 Jan 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 27 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.