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

Healthy Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705610
• Other study ID #: EYE-SEP
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: June 26, 2019

Study information

• Verified date: January 2021
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Healthy
• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Multiple Sclerosis (MS) Primary Progressive
• Multiple Sclerosis (MS) Relapsing Remitting
• Multiple Sclerosis (MS) Secondary Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Radiologically Isolated Syndrome
• Sclerosis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Monaco	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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).	Day 0
Primary	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).	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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).	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0

External Links

•   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