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Completed

NCT Number: NCT04702763

Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Eye-Tracker®T2 + e-VOG

Other
  • 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®T2

Other
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Latency during horizontal reflex saccades

    Time frame: Day 0

    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).

  2. Latency during vertical reflex saccades

    Time frame: Day 0

    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).

  3. Velocity during horizontal reflex saccades

    Time frame: Day 0

    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.

  4. Velocity during vertical reflex saccades

    Time frame: Day 0

    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.

  5. Inhibition capacity

    Time frame: Day 0

    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.

  6. Internuclear ophthalmoplegia (INO) detection

    Time frame: Day 0

    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.

  7. Fixations impairments detection

    Time frame: Day 0

    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.

  8. Impairment of horizontal smooth pursuit

    Time frame: Day 0

    Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device.

    Evaluation criteria: presence/absence of saccade and perturbation.

  9. Impairment of vertical smooth pursuit

    Time frame: Day 0

    Highlight Impairment of horizontal smooth pursuit with e-VOG Compared to standard video-oculography device.

    Evaluation criteria: presence/absence of saccade and perturbation.

  10. Patient acceptability of the e-VOG digital assessment

    Time frame: Day 0

    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.

Sponsors and collaborators

Lead sponsor

Association de Recherche Bibliographique pour les Neurosciences

Other

Collaborators

  • Centre Hospitalier Princesse Grace
  • Centre Hospitalier Universitaire de Nice

Registry information

Official study title

Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography Data in Patients With Multiple Sclerosis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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