Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Demyelinating diseaseMultiple SclerosisVideo-oculographyEye-TrackingEye movementsSubclinical oculomotor abnormalitiesOculomotor 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
+5 more secondary outcomes

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-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

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

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Centre Hospitalier Universitaire de Nice
Othercollaborator
Centre Hospitalier Princesse Grace
Othercollaborator

Study Sites (1)

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

Monaco, 98000, Monaco

MeSH Terms

Conditions

Multiple SclerosisDemyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesAutoimmune DiseasesImmune 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)

Enrollment

30 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations