Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography

NCT ID: NCT04705610

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2019-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to:

* analyze prospectively the prevalence of subclinical oculomotor disorders (OMDs) in different phenotypes of Multiple Sclerosis (MS) and to study correlations with brain MRI T2 data.
* highlight link between modification of visual exploration strategies to decode emotions, and social behavioral disorders, in patients with demyelinating disease, from early to clinically definite stages.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis (MS) Multiple Sclerosis (MS) Relapsing Remitting Multiple Sclerosis (MS) Primary Progressive Multiple Sclerosis (MS) Secondary Progressive Radiologically Isolated Syndrome Clinically Isolated Syndrome Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective, descriptive, comparative (case-control), monocentric study. Control are healthy volunteers. Pathological groups are Radiologically Isolated Syndrome (RIS), Clinically Isolated Syndrome (CIS), Relapsing-Remitting MS (RRMS), Secondary Progressive MS (SPMS) and Primary Progressive MS (PPMS).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiologically Isolated Syndrome (RIS)

Group Type EXPERIMENTAL

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Intervention Type OTHER

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Clinically Isolated Syndrome (CIS)

Group Type EXPERIMENTAL

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Intervention Type OTHER

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Relapsing-Remitting MS (RRMS)

Group Type EXPERIMENTAL

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Intervention Type OTHER

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Secondary Progressive MS (SPMS)

Group Type EXPERIMENTAL

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Intervention Type OTHER

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Primary Progressive MS (PPMS)

Group Type EXPERIMENTAL

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Intervention Type OTHER

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Healthy volunteer

Group Type EXPERIMENTAL

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Intervention Type OTHER

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Video-oculography / Social cognition tasks / Neuropsychological evaluations

* Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
* Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
* Neurological evaluation
* Neuropsychological evaluations
* Social cognitions tasks
* Behaviour assessment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or Female.
* 18 years old and above.
* Sufficient written and oral expression in French.
* Covered by a health insurance system
* Written informed consent signed by the patient.
* For the MS group:

\* Patient diagnosed according to diagnostic criteria established by Polman et al. (2010): Radiologically Isolated Syndrome compatible with MS (RIS), Clinically Isolated Syndrome compatible with MS (CIS), Relapsing-Remitting MS, Secondary Progressive MS, or Primary Progressive MS.

\* Hospitalized or coming to perform a consultation.
* For the control group: No cognitive impairment (non pathological Mini-Mental State Examination (MMSE), according to age, gender and socio-cultural level).

Exclusion Criteria

* General anaesthesia within 3 months.
* Ophthalmological problems preventing a video-oculography examination.
* Oculomotor disorders:

* For the control group: "fixation disorders" or "ocular tracking disorders".
* For the MS group: atypical disorders.
* Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
* Other neurological or ophthalmological disorders than MS
* History of stroke.
* Psychotropic drugs consummation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

Centre Hospitalier Princesse Grace

OTHER

Sponsor Role collaborator

Association de Recherche Bibliographique pour les Neurosciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine LEBRUN-FRENAY, PUPH

Role: PRINCIPAL_INVESTIGATOR

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

Alain PESCE, PUPH

Role: PRINCIPAL_INVESTIGATOR

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

Benoit KULLMANN, MD-PHD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Monaco, , Monaco

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Monaco

Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.1016/j.msard.2020.101969

K. Polet, et al.. Video-oculography in multiple sclerosis: Links between oculomotor disorders and brain magnetic resonance imaging (MRI). Multiple Sclerosis and Related Disorders, 2020-05-01, Volume 40, Article 101969

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EYE-SEP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Emotions in Multiple Sclerosis
NCT04804787 COMPLETED NA