EYE-SEP : Study of Social Cognition in Patients With Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography.

CompletedNot a drug-phase studyRelapsing and progressiveNCT04705610

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Video-oculography / Social cognition tasks / Neuropsychological evaluations

What it measured

Main measures

  • Prevalence of Oculomotor disorders (OMD)

    Day 0

    Nerve conduction tests
  • Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)

    Day 0

    Thinking and memoryNerve conduction tests
  • Eye gaze strategies during Emotion recognition assessment: Facial emotion recognition (FER)

    Day 0

    Thinking and memoryNerve conduction tests

Other measures (17)

  • T2 MRI lesion location: Posterior fossa lesions

    Day 0

    MRI lesions
  • T2 MRI lesion location: Spinal cord lesions

    Day 0

    MRI lesions
  • T2 MRI lesion location: T2 lesions load

    Day 0

    MRI lesions
  • Oculomotor paradigms raw performance - Horizontal saccades

    Day 0

    Myelin repairNerve conduction tests
  • Oculomotor paradigms raw performance - Vertical saccades

    Day 0

    Myelin repairNerve conduction tests
  • Disease Disability

    Day 0

    Disability progression
  • Disease Duration

    Day 0

  • Correlations between visual exploration strategies and behavioral disorders.

    Day 0

    Thinking and memoryNerve conduction tests
  • Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition.

    Day 0

    Thinking and memoryNerve conduction tests
  • Correlations between visual exploration strategies and social cognition impairment: Affective ToM.

    Day 0

    Thinking and memoryNerve conduction tests

Who could take part

Relapsing and progressive · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        May 2017

      2. Main results due

        Jun 2019

      3. Finished

        Jun 2019

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