Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography
- Conditions
- Multiple Sclerosis (MS)HealthyMultiple Sclerosis (MS) Relapsing RemittingMultiple Sclerosis (MS) Primary ProgressiveMultiple Sclerosis (MS) Secondary ProgressiveClinically Isolated SyndromeRadiologically Isolated Syndrome
- Interventions
- Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations
- Registration Number
- NCT04705610
- Lead Sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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Male or Female.
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18 years old and above.
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Sufficient written and oral expression in French.
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Covered by a health insurance system
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Written informed consent signed by the patient.
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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.
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For the control group: No cognitive impairment (non pathological Mini-Mental State Examination (MMSE), according to age, gender and socio-cultural level).
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General anaesthesia within 3 months.
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Ophthalmological problems preventing a video-oculography examination.
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Oculomotor disorders:
- For the control group: "fixation disorders" or "ocular tracking disorders".
- For the MS group: atypical disorders.
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Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
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Other neurological or ophthalmological disorders than MS
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History of stroke.
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Psychotropic drugs consummation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy volunteer Video-oculography / Social cognition tasks / Neuropsychological evaluations - Radiologically Isolated Syndrome (RIS) Video-oculography / Social cognition tasks / Neuropsychological evaluations - Relapsing-Remitting MS (RRMS) Video-oculography / Social cognition tasks / Neuropsychological evaluations - Clinically Isolated Syndrome (CIS) Video-oculography / Social cognition tasks / Neuropsychological evaluations - Primary Progressive MS (PPMS) Video-oculography / Social cognition tasks / Neuropsychological evaluations - Secondary Progressive MS (SPMS) Video-oculography / Social cognition tasks / Neuropsychological evaluations -
- Primary Outcome Measures
Name Time Method Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM) Day 0 Comparison of gaze patterns between control group and pathological groups, during Affective ToM task. Evaluation criteria: number and duration of fixations. Eye movements were recorded with an eye-tracking device. Affective ToM was assessed using the " Reading the Mind in the Eyes " test (Baron-Cohen 2001).
Eye gaze strategies during Emotion recognition assessment: Facial emotion recognition (FER) Day 0 Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: number and duration of fixations on areas of interest. Eye movements were recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).
Prevalence of Oculomotor disorders (OMD) Day 0 To analyze prevalence of OMD in different MS phenotypes Eye movements were recorded and analyzed with an eye-tracking device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, smooth pursuit and anti-saccades). For each subject values were judged abnormal if they differed by \>1.65 Standard Deviation (SD) compared to their reference sample.
- Secondary Outcome Measures
Name Time Method T2 MRI lesion location: T2 lesions load Day 0 T2 MRI performed by subjects in routine care. MRI data were described according to their nature (\>9T2), and classified as present or absent. This is used for correlation study with Oculomotor disorders.
Correlations between Emotion recognition and disability level. Day 0 To study correlations between Affective ToM task and Expanded Disability Status Scale (EDSS). Evaluation criteria: " Reading the Mind in the Eyes " scores (Baron-Cohen 2001).
Disability level were assessed with the Expanded Disability Status Scale.T2 MRI lesion location: Posterior fossa lesions Day 0 T2 MRI performed by subjects in routine care. MRI data were described according to their nature (Posterior fossa lesions/ Brainstem-Cerebellum), and classified as present or absent. This is used for correlation study with Oculomotor disorders.
Disease Disability Day 0 Disease Disability is assessed with the Expanded Disability Status Scale (EDSS), method of quantifying disability in multiple sclerosis. The EDSS scale ranges from 0 to 10 in 0,5-unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. EDSS is used among other things for correlation study with Oculomotor disorders and oculomotor paradigms raw performance.
T2 MRI lesion location: Spinal cord lesions Day 0 T2 MRI performed by subjects in routine care. MRI data were described according to their nature, and classified as present or absent. This is used for correlation study with Oculomotor disorders.
Oculomotor paradigms raw performance - Horizontal saccades Day 0 This concerns saccades Latency (in ms), Main velocity (in °/sec) and Gain (gaze accuracy) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. These outcome measures are used in correlation and comparison analysis.
Oculomotor paradigms raw performance - Vertical saccades Day 0 This concerns saccades Latency (in ms), Main velocity (in °/sec) and Gain (gaze accuracy) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. These outcome measures are used in correlation and comparison analysis.
Disease Duration Day 0 Disease duration corresponds to years of evolution since initial diagnosis of the disease. It is based on an interview with subject's neurologist, or subject's medical file. Disease duration is used among other things for correlation study with Oculomotor disorders and oculomotor paradigms raw performance.
Correlations between visual exploration strategies and behavioral disorders. Day 0 To study correlations between gaze patterns and Neuropsychiatric Inventory (NPI). Evaluation criteria: number and duration of fixations on areas of interest during social cognition task (" Reading the Mind in the Eyes " test (Baron-Cohen 2001) and Ekman Faces task). Eye movements were recorded with an eye-tracking device. Behavior disorders were assessed with the Neuropsychiatric Inventory.
Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition. Day 0 To study correlations between gaze patterns and Facial emotion recognition tasks. Evaluation criteria: number and duration of fixations on areas of interest during Facial emotion recognition tasks (Ekman Faces task). Eye movements were recorded with an eye-tracking device. Facial emotion recognition impairment with the Ekman Faces task.
Correlations between visual exploration strategies and social cognition impairment: Affective ToM. Day 0 To study correlations between gaze patterns and Affective ToM. Evaluation criteria: number and duration of fixations during " Reading the Mind in the Eyes " test (Baron-Cohen 2001)). Eye movements were recorded with an eye-tracking device. Affective ToM impairments with the " Reading the Mind in the Eyes " test (Baron-Cohen 2001).
Correlations between Facial emotion recognition and behavioral disorders. Day 0 To study correlations between Facial emotion recognition tasks and Neuropsychiatric Inventory (NPI). Evaluation criteria: Ekman scores and NPI scores. Behavior disorders were assessed with the Neuropsychiatric Inventory.
Correlations between Emotion recognition and behavioral disorders. Day 0 To study correlations between Affective ToM task and Neuropsychiatric Inventory (NPI). Evaluation criteria: " Reading the Mind in the Eyes " scores (Baron-Cohen 2001). Behavior disorders were assessed with the Neuropsychiatric Inventory.
Correlations between Affective empathy and disability level. Day 0 To study correlations between Affective empathy and Expanded Disability Status Scale (EDSS). Evaluation criteria: The Empathy Quotient (EQ) scores. Disability level were assessed with the Expanded Disability Status Scale.
Eye gaze strategies during exploration of a specific artwork Day 0 Comparison of gaze patterns between control group and pathological groups, during exploration of a specific artwork. Evaluation criteria: difference in exploration strategy (chronology) on target areas.
Correlations between Facial emotion recognition and disability level. Day 0 To study correlations between Facial emotion recognition tasks and Expanded Disability Status Scale (EDSS). Evaluation criteria: Ekman scores and EDSS scores.
Correlations between Cognitive Theory of mind and disability level. Day 0 To study correlations between Cognitive Theory of mind task and Expanded Disability Status Scale (EDSS). Evaluation criteria: TOM-15 scores (TOM-15 a false-belief task to assess cognitive theory of mind). Disability level were assessed with the Expanded Disability Status Scale.
Trial Locations
- Locations (1)
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
🇲🇨Monaco, Monaco