EYE-EMPATH: Assessment of Empathetic Process by Scanpath Study of an Artwork

Sponsor

Centre Hospitalier Princesse Grace (Other)

Overall Status

Completed

CT.gov ID

NCT04665622

Collaborator

Association de Recherche Bibliographique pour les Neurosciences (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Dementia Parkinson Disease Fronto-Temporal Dementia	Other: Eye-Tracking / Neuropsychological evaluations	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A monocentric prospective, descriptive, comparative study.A monocentric prospective, descriptive, comparative study.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Theory of Mind, Empathy and Eye Gaze Strategies During an Artwork Observation in Neurodegenerative Pathologies.

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Fronto-temporal Dementia 10 subjects	Other: Eye-Tracking / Neuropsychological evaluations Use of Eye-Tracking / Neuropsychological évaluations in 4 groups
Other: Alzheimer's Dementia 20 subjects	Other: Eye-Tracking / Neuropsychological evaluations Use of Eye-Tracking / Neuropsychological évaluations in 4 groups
Other: Parkinson's Disease 20 subjects	Other: Eye-Tracking / Neuropsychological evaluations Use of Eye-Tracking / Neuropsychological évaluations in 4 groups
Other: Healthy volunteers 20 subjects	Other: Eye-Tracking / Neuropsychological evaluations Use of Eye-Tracking / Neuropsychological évaluations in 4 groups

Outcome Measures

Primary Outcome Measures

1. Gaze patterns [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 [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 [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.

Secondary Outcome Measures

Cognitive Theory of mind during an artwork observation: Score 1 [Baseline]
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 [Baseline]
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 [Baseline]
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) [Baseline]
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) [Baseline]
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. [Baseline]
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). [Baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.