Alzheimer's DementiaEYE-ToMNCT04748263
Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)
An observational study of Alzheimer's Dementia and Parkinson Disease(PD), run by Centre Hospitalier Princesse Grace.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Alzheimer's Dementia, Parkinson Disease(PD), Fronto-Temporal Dementia
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Adult, Older adult
Study population: Patient 45 years old and above healthy or with FTD, AD or PD pathology
Who may be able to join
- 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).
Who cannot join
- 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.
About this 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.
- Being tested
- No intervention. Only survey and normal use of eye-tracking
- Keywords
- Eye-Tracking, Neuropsychological evaluations
- Medical subject headings
- Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Only survey and normal use of eye-trackingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fronto-Temporal Dementia (FTD) | 10 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. Receives: Other: No intervention. Only survey and normal use of eye-tracking | |
| Alzheimer's Dementia (AD) | 20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. Receives: Other: No intervention. Only survey and normal use of eye-tracking | |
| Parkinson's Disease (PD) | 20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. Receives: Other: No intervention. Only survey and normal use of eye-tracking | |
| Healthy volunteers | 20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. Receives: Other: No intervention. Only survey and normal use of eye-tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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)
Measured: 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).
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Jul 2015
- Primary completion1 Dec 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Collaborators
- Association de Recherche Bibliographique pour les Neurosciences
- Responsible party
- Sponsor
- Investigators
- Alain PESCE, MD-PHD, Principal investigator, CH Princesse GraceSandrine LOUCHART de la CHAPELLE, MD, Principal investigator, CH Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748263
- Sponsor's protocol ID
- 15-05
- Acronym
- EYE-ToM
- Status last verified
- May 2026
- First submitted
- 26 Jan 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)
- ClinicalTrials.gov ID
- NCT04748263
- Acronym / sponsor ID
- EYE-ToM / 15-05
- Keywords
- Eye-Tracking, Neuropsychological evaluations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Collaborators
- Association de Recherche Bibliographique pour les Neurosciences
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fronto-Temporal Dementia (FTD) | – | Other: No intervention. Only survey and normal use of eye-tracking10 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. |
| Alzheimer's Dementia (AD) | – | Other: No intervention. Only survey and normal use of eye-tracking20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. |
| Parkinson's Disease (PD) | – | Other: No intervention. Only survey and normal use of eye-tracking20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. |
| Healthy volunteers | – | Other: No intervention. Only survey and normal use of eye-tracking20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient 45 years old and above healthy or with FTD, AD or PD pathology
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. Only survey and normal use of eye-trackingThe 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. | Other | Alzheimer's Dementia (AD), Fronto-Temporal Dementia (FTD), Healthy volunteers, Parkinson's Disease (PD) |
Primary outcome
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).
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).
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.
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).
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).
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.
3 secondary outcomes
Facial emotion recognition (FER) performances
Time frame: Baseline
Affective ToM performances
Time frame: Baseline
Behavioral disorders.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain PESCE, MD-PHD principal investigator
CH Princesse Grace
Sandrine LOUCHART de la CHAPELLE, MD principal investigator
CH Princesse Grace
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Dementia and Parkinson Disease(PD), run by Centre Hospitalier Princesse Grace.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye gaze strategies (number of eye fixation) during Affective Theory of Mind (ToM) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.