Multiple Sclerosis (MS)EYE-SEPNCT04705610
Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography
A study testing Video-oculography / Social cognition tasks / Neuropsychological evaluations in people with Multiple Sclerosis (MS) and Multiple Sclerosis (MS) Relapsing Remitting, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis (MS), Multiple Sclerosis (MS) Relapsing Remitting, Multiple Sclerosis (MS) Primary Progressive
- What is being tested?
- Video-oculography / Social cognition tasks / Neuropsychological evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteMonaco
- Study dates
- 23 May 2017to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- Other neurological or ophthalmological disorders than MS
- History of stroke.
- Psychotropic drugs consummation.
Trial locations and contacts
1 site in 1 country.
Monaco1 site
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, 98000
About this study
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.
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
- Being tested
- Video-oculography / Social cognition tasks / Neuropsychological evaluations
- Keywords
- Demyelinating disease, Video-oculography, Eye-Tracking, Visual exploration strategies, Oculomotor behaviors, Oculomotor disorders, Emotions recognition, Social behavioral disorders, Social cognition, brain MRI
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-oculography / Social cognition tasks / Neuropsychological evaluationsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Radiologically Isolated Syndrome (RIS) | Experimental | Not described Receives: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations |
| Clinically Isolated Syndrome (CIS) | Experimental | Not described Receives: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations |
| Relapsing-Remitting MS (RRMS) | Experimental | Not described Receives: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations |
| Secondary Progressive MS (SPMS) | Experimental | Not described Receives: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations |
| Primary Progressive MS (PPMS) | Experimental | Not described Receives: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations |
| Healthy volunteer | Experimental | Not described Receives: Other: Video-oculography / Social cognition tasks / Neuropsychological evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Day 0
Secondary outcomes (17)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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).
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start23 May 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, Centre Hospitalier Princesse Grace
- Responsible party
- Sponsor
- Investigators
- Christine LEBRUN-FRENAY, PUPH, Principal investigator, Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-FranceAlain PESCE, PUPH, Principal investigator, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital (Monaco)Benoit KULLMANN, MD-PHD, Study director, AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705610
- Sponsor's protocol ID
- EYE-SEP
- Acronym
- EYE-SEP
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04705610
- Acronym / sponsor ID
- EYE-SEP / EYE-SEP
- 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
- Keywords
- Demyelinating disease, Video-oculography, Eye-Tracking, Visual exploration strategies, Oculomotor behaviors, Oculomotor disorders, Emotions recognition, Social behavioral disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, Centre Hospitalier Princesse Grace
- Study start
- 23 May 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- General anaesthesia within 3 months.
- Ophthalmological problems preventing a video-oculography examination.
- Oculomotor disorders:
- Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
- Other neurological or ophthalmological disorders than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Clinically Isolated Syndrome (CIS), Healthy volunteer, Primary Progressive MS (PPMS), Radiologically Isolated Syndrome (RIS), Relapsing-Remitting MS (RRMS), Secondary Progressive MS (SPMS) |
Primary outcome
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.
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).
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).
17 secondary outcomes
T2 MRI lesion location: Posterior fossa lesions
Time frame: Day 0
T2 MRI lesion location: Spinal cord lesions
Time frame: Day 0
T2 MRI lesion location: T2 lesions load
Time frame: Day 0
Oculomotor paradigms raw performance - Horizontal saccades
Time frame: Day 0
Oculomotor paradigms raw performance - Vertical saccades
Time frame: Day 0
Disease Disability
Time frame: Day 0
Disease Duration
Time frame: Day 0
Correlations between visual exploration strategies and behavioral disorders.
Time frame: Day 0
Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition.
Time frame: Day 0
Correlations between visual exploration strategies and social cognition impairment: Affective ToM.
Time frame: Day 0
Correlations between Facial emotion recognition and behavioral disorders.
Time frame: Day 0
Correlations between Emotion recognition and behavioral disorders.
Time frame: Day 0
Correlations between Facial emotion recognition and disability level.
Time frame: Day 0
Correlations between Emotion recognition and disability level.
Time frame: Day 0
Correlations between Cognitive Theory of mind and disability level.
Time frame: Day 0
Correlations between Affective empathy and disability level.
Time frame: Day 0
Eye gaze strategies during exploration of a specific artwork
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- 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 101969Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine LEBRUN-FRENAY, PUPH principal investigator
Centre de Ressources et de Compétences SEP, UMRC Pasteur 2, Université Nice Côte d'Azur, Nice-France
Alain PESCE, PUPH principal investigator
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital (Monaco)
Benoit KULLMANN, MD-PHD study director
AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-oculography / Social cognition tasks / Neuropsychological evaluations in people with Multiple Sclerosis (MS) and Multiple Sclerosis (MS) Relapsing Remitting, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Oculomotor disorders (OMD) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.