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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease(PD); Alzheimer's Dementia; Fronto-Temporal Dementia
• Intervention / Treatment: Other: No intervention. Only survey and normal use of eye-tracking

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient 45 years old and above healthy or with FTD, AD or PD pathology

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Princesse Grace
• Collaborators: Association de Recherche Bibliographique pour les Neurosciences
• Investigators: Principal Investigator: Alain PESCE, MD-PHD, CH Princesse Grace; Principal Investigator: Sandrine LOUCHART de la CHAPELLE, MD, CH Princesse Grace

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Eye-Tracking; Neuropsychological evaluations
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Parkinson Disease; Dementia; Alzheimer Disease; Neurodegenerative Diseases; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: 15-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No