Back to resultsAssessment of Empathetic Process by Scanpath Study of an Artwork (EYE-EMPATH)
Primary Purpose
Alzheimer Dementia, Parkinson Disease, Fronto-Temporal Dementia
Status
Completed
Phase
Not Applicable
Locations
Monaco
Study Type
Interventional
Intervention
Eye-Tracking / Neuropsychological evaluations
Sponsored by
About this trial
This is an interventional other trial for Alzheimer Dementia focused on measuring Eye-Tracking, Empathy, Social cognition, Theory of Mind, Scanpath, Gaze
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Centre Hospitalier Princesse Grace
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Fronto-temporal Dementia
Alzheimer's Dementia
Parkinson's Disease
Healthy volunteers
Arm Description
10 subjects
20 subjects
20 subjects
20 subjects
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
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).
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).
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.
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.
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.
Affective empathy: Score 4.
Intensity of the emotion felt by the participant following observation of the table, using an EVA scale [0-10].
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.
Full Information
NCT ID
NCT04665622
First Posted
March 8, 2017
Last Updated
March 8, 2022
Sponsor
Centre Hospitalier Princesse Grace
Collaborators
Association de Recherche Bibliographique pour les Neurosciences
1. Study Identification
Unique Protocol Identification Number
NCT04665622
Brief Title
Assessment of Empathetic Process by Scanpath Study of an Artwork
Acronym
EYE-EMPATH
Official Title
Theory of Mind, Empathy and Eye Gaze Strategies During an Artwork Observation in Neurodegenerative Pathologies.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Princesse Grace
Collaborators
Association de Recherche Bibliographique pour les Neurosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Dementia, Parkinson Disease, Fronto-Temporal Dementia
Keywords
Eye-Tracking, Empathy, Social cognition, Theory of Mind, Scanpath, Gaze
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A monocentric prospective, descriptive, comparative study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fronto-temporal Dementia
Arm Type
Other
Arm Description
10 subjects
Arm Title
Alzheimer's Dementia
Arm Type
Other
Arm Description
20 subjects
Arm Title
Parkinson's Disease
Arm Type
Other
Arm Description
20 subjects
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
20 subjects
Intervention Type
Other
Intervention Name(s)
Eye-Tracking / Neuropsychological evaluations
Intervention Description
Use of Eye-Tracking / Neuropsychological évaluations in 4 groups
Primary Outcome Measure Information:
Title
1. Gaze patterns
Description
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
Time Frame
baseline
Title
2.Gaze Patterns
Description
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.
Time Frame
Baseline
Title
3.Gaze Patterns
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Cognitive Theory of mind during an artwork observation: Score 1
Description
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).
Time Frame
Baseline
Title
Cognitive Theory of mind during an artwork observation: Score 2
Description
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).
Time Frame
Baseline
Title
Cognitive Theory of mind: TOM-15 a false-belief task to assess cognitive theory of mind
Description
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.
Time Frame
Baseline
Title
Affective ToM (Score 3)
Description
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.
Time Frame
Baseline
Title
Affective ToM : The Reading the Mind in the Eye test - RME - (Baron-Cohen S at al., 2001)
Description
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.
Time Frame
Baseline
Title
Affective empathy: Score 4.
Description
Intensity of the emotion felt by the participant following observation of the table, using an EVA scale [0-10].
Time Frame
Baseline
Title
Affective empathy: The Empathy Quotient (EQ).
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Centre Hospitalier Princesse Grace
City
Monaco
ZIP/Postal Code
98000
Country
Monaco
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Empathetic Process by Scanpath Study of an Artwork
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