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Completed

NCT Number: NCT04748263

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

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.

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Key information

Conditions

Alzheimer's Dementia Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Fronto-Temporal Dementia Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinson Disease(PD) Parkinsonian Disorders Synucleinopathies Tauopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention. Only survey and normal use of eye-tracking

Other

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.

Primary outcomes

  1. Eye gaze strategies (number of eye fixation) during Affective Theory of Mind (ToM)

    Time frame: Baseline

    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).

  2. Eye gaze strategies (duration of eye fixations) during Affective Theory of Mind (ToM)

    Time frame: Baseline

    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).

  3. Eye gaze strategies (response times) during Affective Theory of Mind (ToM)

    Time frame: Baseline

    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.

  4. Eye gaze strategies (number of eye fixation) during Facial emotion recognition (FER)

    Time frame: Baseline

    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).

  5. Eye gaze strategies (duration of eye fixation) during Facial emotion recognition (FER)

    Time frame: Baseline

    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).

  6. Eye gaze strategies (response times) during Facial emotion recognition (FER)

    Time frame: Baseline

    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.

Secondary outcomes

  1. Facial emotion recognition (FER) performances

    Time frame: Baseline

    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)

  2. Affective ToM performances

    Time frame: Baseline

    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).

  3. Behavioral disorders.

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Collaborators

  • Association de Recherche Bibliographique pour les Neurosciences

Registry information

Acronym: EYE-ToM

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Feb 10, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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