Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)

Study Overview
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Brief Summary
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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.

Official Title
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Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)

Conditions
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Alzheimer's Dementia, Parkinson Disease(PD), Fronto-Temporal Dementia

Intervention / Treatment
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* Other: No intervention. Only survey and normal use of eye-tracking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fronto-Temporal Dementia (FTD)<br>10 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. | Other: No intervention. Only survey and normal use of eye-tracking<br>* 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.<br>|
| Alzheimer's Dementia (AD)<br>20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. | Other: No intervention. Only survey and normal use of eye-tracking<br>* 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.<br>|
| Parkinson's Disease (PD)<br>20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. | Other: No intervention. Only survey and normal use of eye-tracking<br>* 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.<br>|
| Healthy volunteers<br>20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. | Other: No intervention. Only survey and normal use of eye-tracking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial emotion recognition (FER) performances | Affective ToM performances, and behavioral disorders. Evaluation criteria: Scores (/28) and sub-score (/6) to Ekman Faces task (1976). The Ekman Faces task (1976) tests the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral) | Baseline | 
| Affective ToM performances | To study correlations between eye gaze strategies, Facial emotion recognition and Affective ToM performances, and behavioral disorders. Evaluation criteria: Scores to the  Reading the Mind in the Eyes  test (Baron-Cohen 2001). 36 black-and-white photographs of the eye area of faces. Subjects are asked to choose which word, among four options, best described what the character in the photograph was thinking or feeling. For this task, four scores were obtained: a total score (/36) and three emotional valence sub-scores: positive (/8), neutral (/16) and negative (/12). | Baseline | 
| Behavioral disorders. | To study correlations between eye gaze strategies, Facial emotion recognition and Affective ToM performances, and behavioral disorders. Evaluation criteria: Neuropsychiatric Inventory (NPI), a scale that includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). Both the frequency (/5) and the severity (/3) of each behavior were determined and a score was calculated by multiplying the frequency and the severity of each behavior observed during the last month. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye-Tracking, Neuropsychological evaluations