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

Association de Recherche Bibliographique pour les Neurosciences

Status: Completed

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

Treatments: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Study type: Interventional

Funder types: Other

Identifiers

NCT04705610

EYE-SEP

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 6 patient groups

Radiologically Isolated Syndrome (RIS)

Experimental group

Treatment:

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Clinically Isolated Syndrome (CIS)

Experimental group

Treatment:

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Relapsing-Remitting MS (RRMS)

Experimental group

Treatment:

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Secondary Progressive MS (SPMS)

Experimental group

Treatment:

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Primary Progressive MS (PPMS)

Experimental group

Treatment:

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Healthy volunteer

Experimental group

Treatment:

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations