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

Sponsor

Association de Recherche Bibliographique pour les Neurosciences (Other)

Overall Status

Completed

CT.gov ID

NCT04705610

Collaborator

Centre Hospitalier Universitaire de Nice (Other), Centre Hospitalier Princesse Grace (Other)

Enrollment

Location

Arms

25.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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)

Primary Purpose:

Other

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.

Actual Study Start Date :

May 23, 2017

Actual Primary Completion Date :

Jun 26, 2019

Actual Study Completion Date :

Jun 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiologically Isolated Syndrome (RIS)	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations 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
Experimental: Clinically Isolated Syndrome (CIS)	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations 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
Experimental: Relapsing-Remitting MS (RRMS)	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations 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
Experimental: Secondary Progressive MS (SPMS)	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations 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
Experimental: Primary Progressive MS (PPMS)	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations 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
Experimental: Healthy volunteer	Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations 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

Outcome Measures

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
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 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.
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 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 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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco		Monaco	98000

Sponsors and Collaborators

Association de Recherche Bibliographique pour les Neurosciences
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Princesse Grace

Investigators

Principal Investigator: Christine LEBRUN-FRENAY, PUPH, Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
Principal Investigator: Alain PESCE, PUPH, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital (Monaco)
Study Director: Benoit KULLMANN, MD-PHD, AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)