Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)
EYE-ToM
1 other identifier
observational
70
0 countries
N/A
Brief Summary
It is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (Theory of Mind), are associated with social behavior disorders. This kind of disorders are observed in Fronto-Temporal Dementia (FTD), Alzheimer's Dementia (AD) and Parkinson's Disease (PD), with severe deficits in FTD and lighter deficits in AD and PD. One explanation might be that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others. This study aims to test this hypothesis and further to analyse whether different patterns emerge from these pathologies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 26, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedFebruary 10, 2021
February 1, 2021
4.4 years
January 26, 2021
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Eye gaze strategies (number of eye fixation) during Affective Theory of Mind (ToM)
Comparison of gaze patterns between control group and pathological groups, during Affective ToM task Evaluation criteria: number of eye fixation. 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).
Baseline
Eye gaze strategies (duration of eye fixations) during Affective Theory of Mind (ToM)
Comparison of gaze patterns between control group and pathological groups, during Affective ToM task. Evaluation criteria: duration of eye 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).
Baseline
Eye gaze strategies (response times) during Affective Theory of Mind (ToM)
Evaluation criteria: time to answer for each picture (in second). It was recorded using the eye-tracking device. Affective ToM was assessed using 36 pictures from the " Reading the Mind in the Eyes " test (Baron-Cohen 2001), with a maximum of 8 seconds of response time per picture.
Baseline
Eye gaze strategies (number of eye fixation) during Facial emotion recognition (FER)
Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: number of eye fixation. Eye movements were recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).
Baseline
Eye gaze strategies (duration of eye fixation) during Facial emotion recognition (FER)
Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: duration of eye fixations. Eye movements were recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).
Baseline
Eye gaze strategies (response times) during Facial emotion recognition (FER)
Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: time to answer for each picture (in second). It was recorded using the eye-tracking device. Facial emotion recognition was assessed using 28 pictures from The Ekman Faces task (1976), with a maximum of 8 seconds of response time per picture.
Baseline
Secondary Outcomes (3)
Facial emotion recognition (FER) performances
Baseline
Affective ToM performances
Baseline
Behavioral disorders.
Baseline
Study Arms (4)
Fronto-Temporal Dementia (FTD)
10 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.
Alzheimer's Dementia (AD)
20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.
Parkinson's Disease (PD)
20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.
Healthy volunteers
20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.
Interventions
The study is conducted in accordance with usual practices of eye-tracking and neuropsychological evaluations carried out at the Center Rainier III. Eye-Tracker® is used at the Centre Rainier III since August 2014. It is a non-invasive device for eye movements recording, allowing doctors and researchers to measure standard parameters related to eye movements. Developed by the Eye Brain Company (France), this is a Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE.
Eligibility Criteria
Patient 45 years old and above healthy or with FTD, AD or PD pathology
You may qualify if:
- Hospitalized or coming to perform a consultation, for whom an Eye-Tracking examination is indicated as part of routine care.
- Sufficient written and oral expression in French.
- Written informed consent signed by the patient.
- For the control group: No cognitive impairment (non pathological MMSE (according to age, gender and socio-cultural level), no neurological history, and no psychiatric history (especially anxiety and depressive disorders).
- For the FTD group: Patient diagnosed according to revised Rascovsky et al. 2011., no neurological history (excepted diagnosed FTD), and no psychiatric history (excepted those related to diagnosed FTD).
- For the AD group: Patient diagnosed according to DSM-IV-TR criteria, no neurological history (excepted diagnosed AD), and no psychiatric history (excepted those related to diagnosed AD).
- For the PD group: Patient diagnosed according to NINDS criteria, no neurological history (excepted diagnosed PD), and no psychiatric history (excepted those related to diagnosed PD).
You may not qualify if:
- General anaesthesia within 3 months.
- Ophthalmological problems preventing a video-oculography examination.
- Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
- Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
- History of stroke.
- History of alcohol or drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain PESCE, MD-PHD
CH Princesse Grace
- PRINCIPAL INVESTIGATOR
Sandrine LOUCHART de la CHAPELLE, MD
CH Princesse Grace
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2021
First Posted
February 10, 2021
Study Start
July 1, 2015
Primary Completion
December 1, 2019
Study Completion
November 1, 2020
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share