Alzheimer DementiaEYE-EMPATHNCT04665622
Assessment of Empathetic Process by Scanpath Study of an Artwork
A study testing Eye-Tracking / Neuropsychological evaluations in people with Alzheimer Dementia and Parkinson Disease, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
Analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as Fronto-Temporal Dementia, Alzheimer's Dementia or Parkinson's Disease Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia, Parkinson Disease, Fronto-Temporal Dementia
- What is being tested?
- Eye-Tracking / Neuropsychological evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMonaco
- Study dates
- 1 Apr 2016to 31 Dec 2019
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female.
- 60 years old and above.
- Sufficient written and oral expression in French.
- Benefit from French or Monaco Social security.
- Written informed consent signed by the patient.
- For the control group: voluntary subjects, without cognitive impairment.
- For the FTD / AD / PD groups: patients diagnosed with one of these diseases, and volunteers to participate in the study.
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".
- History of stroke.
- Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Theory of Mind, Empathy and Eye Gaze Strategies During an Artwork Observation in Neurodegenerative Pathologies.
Analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as Fronto-Temporal Dementia, Alzheimer's Dementia or Parkinson's Disease
- Being tested
- Eye-Tracking / Neuropsychological evaluations
- Keywords
- Eye-Tracking, Empathy, Social cognition, Theory of Mind, Scanpath, Gaze
- 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.
Eye-Tracking / Neuropsychological evaluationsOther
Use of Eye-Tracking / Neuropsychological évaluations in 4 groups
| Study group | Role | What they receive |
|---|---|---|
| Fronto-temporal Dementia | Other | 10 subjects Receives: Other: Eye-Tracking / Neuropsychological evaluations |
| Alzheimer's Dementia | Other | 20 subjects Receives: Other: Eye-Tracking / Neuropsychological evaluations |
| Parkinson's Disease | Other | 20 subjects Receives: Other: Eye-Tracking / Neuropsychological evaluations |
| Healthy volunteers | Other | 20 subjects Receives: Other: Eye-Tracking / Neuropsychological evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Gaze patterns
Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in the number of fixation
Measured: baseline
2.Gaze Patterns
Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in exploration strategy (chronology) on target areas.
Measured: Baseline
3.Gaze Patterns
Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in time spent on target areas.
Measured: Baseline
Secondary outcomes (7)
Cognitive Theory of mind during an artwork observation: Score 1
Subject's estimation of the distance perceived by the character represented on the artwork, at a 1st and a 2nd observation of the painting. Score 1 is the ratio of estimated distances (distance2/distance1).
Measured: Baseline
Cognitive Theory of mind during an artwork observation: Score 2
Subject's estimation of the time perceived by the character represented on the artwork, at a 1st and a 2nd observation of the painting. Score 2 is the ratio of estimated times (time2 / time1).
Measured: Baseline
Cognitive Theory of mind: TOM-15 a false-belief task to assess cognitive theory of mind
The task presents 15 stories. The subject must answer the question asked by choosing among two propositions, the correct answer consisting in attributing the correct belief to the character represented. Total score (/ 15).
ToM 15 is used as reference test for correlation study with score1 and score 2.
Measured: Baseline
Affective ToM (Score 3)
At observation, 1 and 2, subject must attribute an emotion to the character represented on the artwork, choosing an answer among 6 propositions: 3 negative mental states, 2 neutral and 1 positive.
Score 3 rating : 2 points if a negative emotion is attributed to the 1st and 2nd observation; 1 point if the negative emotion is attributed only to the 2nd observation; 0.5 point if the negative emotion is attributed only to the 1st observation; 0 point if no negative emotion is attributed.
Measured: Baseline
Affective ToM : The Reading the Mind in the Eye test - RME - (Baron-Cohen S at al., 2001)
The task consisted of 36 black-and-white photographs of the eye area of faces. Subject is asked to choose which word, among four options, best described what the character in the photograph was thinking or feeling. Total score (/36) and three emotional valence sub-scores: positive (/8), neutral (/16) and negative (/12) according to the procedure described by Harkness et al., 2005.
RME is used as reference test for correlation study with Score 3.
Measured: Baseline
Affective empathy: Score 4.
Intensity of the emotion felt by the participant following observation of the table, using an EVA scale [0-10].
Measured: Baseline
Affective empathy: The Empathy Quotient (EQ).
Self-administered questionnaire of 40 questions. Participant must choose one of the four propositions ("strongly agree", "tend to agree", "tend to disagree", "strongly disagree") awarding 0, 1 or 2 points. Total Score / 60.
EQ is used as reference test for correlation study with Score 4.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Apr 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A monocentric prospective, descriptive, comparative study.
- Masking
- None (open label)
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665622
- Sponsor's protocol ID
- EYE-EMPATH
- Acronym
- EYE-EMPATH
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2017
- Last updated
- 9 Mar 2022
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory of Mind, Empathy and Eye Gaze Strategies During an Artwork Observation in Neurodegenerative Pathologies.
- ClinicalTrials.gov ID
- NCT04665622
- Acronym / sponsor ID
- EYE-EMPATH / EYE-EMPATH
- Keywords
- Eye-Tracking, Empathy, Social cognition, Theory of Mind, Scanpath, Gaze
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Collaborators
- Association de Recherche Bibliographique pour les Neurosciences
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Dec 2020 (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.
Analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as Fronto-Temporal Dementia, Alzheimer's Dementia or Parkinson's Disease
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A monocentric prospective, descriptive, comparative study.
| Arm | Type | Receives |
|---|---|---|
| Fronto-temporal Dementia | Other | Other: Eye-Tracking / Neuropsychological evaluations10 subjects |
| Alzheimer's Dementia | Other | Other: Eye-Tracking / Neuropsychological evaluations20 subjects |
| Parkinson's Disease | Other | Other: Eye-Tracking / Neuropsychological evaluations20 subjects |
| Healthy volunteers | Other | Other: Eye-Tracking / Neuropsychological evaluations20 subjects |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female.
- 60 years old and above.
- Sufficient written and oral expression in French.
- Benefit from French or Monaco Social security.
- Written informed consent signed by the patient.
Key exclusion criteria (5 listed)
- General anaesthesia within 3 months.
- Ophthalmological problems preventing a video-oculography examination.
- Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
- History of stroke.
- Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
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 |
|---|---|---|
| Eye-Tracking / Neuropsychological evaluationsUse of Eye-Tracking / Neuropsychological évaluations in 4 groups | Other | Alzheimer's Dementia, Fronto-temporal Dementia, Healthy volunteers, Parkinson's Disease |
Primary outcome
1. Gaze patterns
Time frame: baseline
Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in the number of fixation
2.Gaze Patterns
Time frame: Baseline
Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in exploration strategy (chronology) on target areas.
3.Gaze Patterns
Time frame: Baseline
Comparison of gaze patterns between the control group and the pathological groups, during standardized exploration of a specific artwork. Evaluation criteria: difference in time spent on target areas.
7 secondary outcomes
Cognitive Theory of mind during an artwork observation: Score 1
Time frame: Baseline
Cognitive Theory of mind during an artwork observation: Score 2
Time frame: Baseline
Cognitive Theory of mind: TOM-15 a false-belief task to assess cognitive theory of mind
Time frame: Baseline
Affective ToM (Score 3)
Time frame: Baseline
Affective ToM : The Reading the Mind in the Eye test - RME - (Baron-Cohen S at al., 2001)
Time frame: Baseline
Affective empathy: Score 4.
Time frame: Baseline
Affective empathy: The Empathy Quotient (EQ).
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 9 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-Tracking / Neuropsychological evaluations in people with Alzheimer Dementia and Parkinson Disease, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
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 5 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
1. Gaze patterns (time frame: baseline). The study lists 3 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 9 Mar 2022.