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

NCT04702763 | Completed

• 1 other identifier: e-VOG
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Demyelinating disease; Multiple Sclerosis; Video-oculography; Eye-Tracking; Eye movements; Subclinical oculomotor abnormalities; Oculomotor disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0

Secondary Outcomes (10)

• Latency during horizontal reflex saccades

  Day 0

• Latency during vertical reflex saccades

  Day 0

• Velocity during horizontal reflex saccades

  Day 0

• Velocity during vertical reflex saccades

  Day 0

• Inhibition capacity

  Day 0

Study Arms (2)

Multiple Sclerosis (Eye-Tracker®T2 + e-VOG)

Multiple Sclerosis subjects who first perform standard video-oculography assessment, followed by e-VOG digital assessment.

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.

Other: e-VOG + Eye-Tracker®T2

Interventions

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

Multiple Sclerosis (Eye-Tracker®T2 + e-VOG)

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

Multiple Sclerosis (e-VOG + Eye-Tracker®T2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Male or Female.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association de Recherche Bibliographique pour les Neurosciences: lead
• Centre Hospitalier Princesse Grace: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator

Study Sites (1)

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

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mikael COHEN, MD

  Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France

  PRINCIPAL INVESTIGATOR

• Christine LEBRUN-FRENAY, PUPH

  Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France

  PRINCIPAL INVESTIGATOR

• Sandrine LOUCHART DE LA CHAPELLE, MD-PHD

  Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco

  PRINCIPAL INVESTIGATOR

• Alain PESCE, PUPH

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: October 8, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)