Clinical trial NCT04705610: Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography
Official title: EYE-SEP : Study of Social Cognition in Patients With Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Demyelinating disease
Video-oculography
Eye-Tracking
Visual exploration strategies
Oculomotor behaviors
Oculomotor disorders
Emotions recognition
Social behavioral disorders
Social cognition
brain MRI
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
name: Centre Hospitalier Princesse Grace
First posted: 2021-01-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Oculomotor disorders (OMD)
timeFrame: Day 0
measure: Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)
timeFrame: Day 0
measure: Eye gaze strategies during Emotion recognition assessment: Facial emotion recognition (FER)
timeFrame: Day 0
Secondary outcomes:
measure: T2 MRI lesion location: Posterior fossa lesions
timeFrame: Day 0
measure: T2 MRI lesion location: Spinal cord lesions
timeFrame: Day 0
measure: T2 MRI lesion location: T2 lesions load
timeFrame: Day 0
measure: Oculomotor paradigms raw performance - Horizontal saccades
timeFrame: Day 0
measure: Oculomotor paradigms raw performance - Vertical saccades
timeFrame: Day 0
measure: Disease Disability
timeFrame: Day 0
measure: Disease Duration
timeFrame: Day 0
measure: Correlations between visual exploration strategies and behavioral disorders.
timeFrame: Day 0
measure: Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition.
timeFrame: Day 0
measure: Correlations between visual exploration strategies and social cognition impairment: Affective ToM.
timeFrame: Day 0
measure: Correlations between Facial emotion recognition and behavioral disorders.
timeFrame: Day 0
measure: Correlations between Emotion recognition and behavioral disorders.
timeFrame: Day 0
measure: Correlations between Facial emotion recognition and disability level.
timeFrame: Day 0
measure: Correlations between Emotion recognition and disability level.
timeFrame: Day 0
measure: Correlations between Cognitive Theory of mind and disability level.
timeFrame: Day 0
measure: Correlations between Affective empathy and disability level.
timeFrame: Day 0
measure: Eye gaze strategies during exploration of a specific artwork
timeFrame: Day 0
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Study officials:
affiliation: Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
name: Christine LEBRUN-FRENAY, PUPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital (Monaco)
name: Alain PESCE, PUPH
role: PRINCIPAL_INVESTIGATOR
affiliation: AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
name: Benoit KULLMANN, MD-PHD
role: STUDY_DIRECTOR
References: