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

Alzheimer's Dementia Clinical Trial

— EYE-ToM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748263
• Other study ID #: 15-05
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: November 1, 2020

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Princesse Grace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2020
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Dementia
• Aphasia, Primary Progressive
• Dementia
• Fronto-Temporal Dementia
• Frontotemporal Dementia
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinson Disease(PD)
• Pick Disease of the Brain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Princesse Grace	Association de Recherche Bibliographique pour les Neurosciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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