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

NCT04705610 | Completed

• 1 other identifier: EYE-SEP
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (17)

• T2 MRI lesion location: Posterior fossa lesions

  Day 0

• T2 MRI lesion location: Spinal cord lesions

  Day 0

• T2 MRI lesion location: T2 lesions load

  Day 0

• Oculomotor paradigms raw performance - Horizontal saccades

  Day 0

• Oculomotor paradigms raw performance - Vertical saccades

  Day 0

Study Arms (6)

Radiologically Isolated Syndrome (RIS)

EXPERIMENTAL

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Clinically Isolated Syndrome (CIS)

EXPERIMENTAL

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Relapsing-Remitting MS (RRMS)

EXPERIMENTAL

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Secondary Progressive MS (SPMS)

EXPERIMENTAL

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Primary Progressive MS (PPMS)

EXPERIMENTAL

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Healthy volunteer

EXPERIMENTAL

Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations

Interventions

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

Clinically Isolated Syndrome (CIS); Healthy volunteer; Primary Progressive MS (PPMS); Radiologically Isolated Syndrome (RIS); Relapsing-Remitting MS (RRMS); Secondary Progressive MS (SPMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association de Recherche Bibliographique pour les Neurosciences: lead
• Centre Hospitalier Universitaire de Nice: collaborator
• Centre Hospitalier Princesse Grace: collaborator

Study Sites (1)

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

Monaco, 98000, Monaco

Location

Related 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

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• Benoit KULLMANN, MD-PHD

  AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 12, 2021
• Study Start: May 23, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

MO (1)