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

Primary Purpose

Multiple Sclerosis (MS), Multiple Sclerosis (MS) Relapsing Remitting, Multiple Sclerosis (MS) Primary Progressive

Status
Completed
Phase
Not Applicable
Locations
Monaco
Study Type
Interventional
Intervention
Video-oculography / Social cognition tasks / Neuropsychological evaluations
Sponsored by
Association de Recherche Bibliographique pour les Neurosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis (MS) focused on measuring Demyelinating disease, Video-oculography, Eye-Tracking, Visual exploration strategies, Oculomotor behaviors, Oculomotor disorders, Emotions recognition, Social behavioral disorders, Social cognition, brain MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Radiologically Isolated Syndrome (RIS)

Clinically Isolated Syndrome (CIS)

Relapsing-Remitting MS (RRMS)

Secondary Progressive MS (SPMS)

Primary Progressive MS (PPMS)

Healthy volunteer

Arm Description

Outcomes

Primary Outcome Measures

Prevalence of Oculomotor disorders (OMD)
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.
Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)
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)
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 Outcome Measures

T2 MRI lesion location: Posterior fossa lesions
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.
T2 MRI lesion location: Spinal cord lesions
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.
T2 MRI lesion location: T2 lesions load
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.
Oculomotor paradigms raw performance - Horizontal saccades
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
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 Disability
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.
Disease Duration
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.
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.
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.
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.
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.
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 Facial emotion recognition and disability level.
To study correlations between Facial emotion recognition tasks and Expanded Disability Status Scale (EDSS). Evaluation criteria: Ekman scores and EDSS scores.
Correlations between Emotion recognition and disability level.
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.
Correlations between Cognitive Theory of mind and disability level.
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.
Correlations between Affective empathy and disability level.
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
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.

Full Information

First Posted
January 6, 2021
Last Updated
January 19, 2021
Sponsor
Association de Recherche Bibliographique pour les Neurosciences
Collaborators
Centre Hospitalier Universitaire de Nice, Centre Hospitalier Princesse Grace
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1. Study Identification

Unique Protocol Identification Number
NCT04705610
Brief Title
Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography
Acronym
EYE-SEP
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association de Recherche Bibliographique pour les Neurosciences
Collaborators
Centre Hospitalier Universitaire de Nice, Centre Hospitalier Princesse Grace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiologically Isolated Syndrome (RIS)
Arm Type
Experimental
Arm Title
Clinically Isolated Syndrome (CIS)
Arm Type
Experimental
Arm Title
Relapsing-Remitting MS (RRMS)
Arm Type
Experimental
Arm Title
Secondary Progressive MS (SPMS)
Arm Type
Experimental
Arm Title
Primary Progressive MS (PPMS)
Arm Type
Experimental
Arm Title
Healthy volunteer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Video-oculography / Social cognition tasks / Neuropsychological evaluations
Intervention Description
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 Outcome Measure Information:
Title
Prevalence of Oculomotor disorders (OMD)
Description
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.
Time Frame
Day 0
Title
Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)
Description
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).
Time Frame
Day 0
Title
Eye gaze strategies during Emotion recognition assessment: Facial emotion recognition (FER)
Description
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).
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
T2 MRI lesion location: Posterior fossa lesions
Description
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.
Time Frame
Day 0
Title
T2 MRI lesion location: Spinal cord lesions
Description
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.
Time Frame
Day 0
Title
T2 MRI lesion location: T2 lesions load
Description
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.
Time Frame
Day 0
Title
Oculomotor paradigms raw performance - Horizontal saccades
Description
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.
Time Frame
Day 0
Title
Oculomotor paradigms raw performance - Vertical saccades
Description
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.
Time Frame
Day 0
Title
Disease Disability
Description
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.
Time Frame
Day 0
Title
Disease Duration
Description
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.
Time Frame
Day 0
Title
Correlations between visual exploration strategies and behavioral disorders.
Description
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.
Time Frame
Day 0
Title
Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition.
Description
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.
Time Frame
Day 0
Title
Correlations between visual exploration strategies and social cognition impairment: Affective ToM.
Description
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).
Time Frame
Day 0
Title
Correlations between Facial emotion recognition and behavioral disorders.
Description
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.
Time Frame
Day 0
Title
Correlations between Emotion recognition and behavioral disorders.
Description
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.
Time Frame
Day 0
Title
Correlations between Facial emotion recognition and disability level.
Description
To study correlations between Facial emotion recognition tasks and Expanded Disability Status Scale (EDSS). Evaluation criteria: Ekman scores and EDSS scores.
Time Frame
Day 0
Title
Correlations between Emotion recognition and disability level.
Description
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.
Time Frame
Day 0
Title
Correlations between Cognitive Theory of mind and disability level.
Description
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.
Time Frame
Day 0
Title
Correlations between Affective empathy and disability level.
Description
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.
Time Frame
Day 0
Title
Eye gaze strategies during exploration of a specific artwork
Description
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine LEBRUN-FRENAY, PUPH
Organizational Affiliation
Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain PESCE, PUPH
Organizational Affiliation
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital (Monaco)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benoit KULLMANN, MD-PHD
Organizational Affiliation
AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
Official's Role
Study Director
Facility Information:
Facility Name
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
City
Monaco
ZIP/Postal Code
98000
Country
Monaco

12. IPD Sharing Statement

Links:
URL
https://doi.org/10.1016/j.msard.2020.101969
Description
K. Polet, et al.. Video-oculography in multiple sclerosis: Links between oculomotor disorders and brain magnetic resonance imaging (MRI). Multiple Sclerosis and Related Disorders, 2020-05-01, Volume 40, Article 101969

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

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