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
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.
COMPLETED
NA
76 participants
INTERVENTIONAL
2017-05-23
2019-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
NCT02290587
Advanced MRI Sequences in Multiple Sclerosis and Its Mimics
NCT03608605
CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS
NCT02543788
Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis
NCT01207856
MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive Training in Patients with Multiple Sclerosis
NCT04806568
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Radiologically Isolated Syndrome (RIS)
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
Clinically Isolated Syndrome (CIS)
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
Relapsing-Remitting MS (RRMS)
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
Secondary Progressive MS (SPMS)
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
Primary Progressive MS (PPMS)
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
Healthy volunteer
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Nice
OTHER
Centre Hospitalier Princesse Grace
OTHER
Association de Recherche Bibliographique pour les Neurosciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
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.