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Completed

NCT Number: NCT04705610

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

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.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Clinically Isolated Syndrome Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Healthy Immune System Diseases Multiple Sclerosis Multiple Sclerosis (MS) Primary Progressive Multiple Sclerosis (MS) Relapsing Remitting Multiple Sclerosis (MS) Secondary Progressive Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiologically Isolated Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video-oculography / Social cognition tasks / Neuropsychological evaluations

Other
  • 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 outcomes

  1. Prevalence of Oculomotor disorders (OMD)

    Time frame: 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.

  2. Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)

    Time frame: 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).

  3. Eye gaze strategies during Emotion recognition assessment: Facial emotion recognition (FER)

    Time frame: 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).

Secondary outcomes

  1. T2 MRI lesion location: Posterior fossa lesions

    Time frame: 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.

  2. T2 MRI lesion location: Spinal cord lesions

    Time frame: 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.

  3. T2 MRI lesion location: T2 lesions load

    Time frame: 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.

  4. Oculomotor paradigms raw performance - Horizontal saccades

    Time frame: 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.

  5. Oculomotor paradigms raw performance - Vertical saccades

    Time frame: 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.

  6. Disease Disability

    Time frame: 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.

  7. Disease Duration

    Time frame: 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.

  8. Correlations between visual exploration strategies and behavioral disorders.

    Time frame: 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.

  9. Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition.

    Time frame: 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.

  10. Correlations between visual exploration strategies and social cognition impairment: Affective ToM.

    Time frame: 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).

  11. Correlations between Facial emotion recognition and behavioral disorders.

    Time frame: 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.

  12. Correlations between Emotion recognition and behavioral disorders.

    Time frame: 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.

  13. Correlations between Facial emotion recognition and disability level.

    Time frame: Day 0

    To study correlations between Facial emotion recognition tasks and Expanded Disability Status Scale (EDSS). Evaluation criteria: Ekman scores and EDSS scores.

  14. Correlations between Emotion recognition and disability level.

    Time frame: 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.

  15. Correlations between Cognitive Theory of mind and disability level.

    Time frame: 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.

  16. Correlations between Affective empathy and disability level.

    Time frame: 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.

  17. Eye gaze strategies during exploration of a specific artwork

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Association de Recherche Bibliographique pour les Neurosciences

Other

Collaborators

  • Centre Hospitalier Princesse Grace
  • Centre Hospitalier Universitaire de Nice

Registry information

Official study title

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

Acronym: EYE-SEP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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