Assessment of Empathetic Process by Scanpath Study of an Artwork

Not Applicable

Completed

• Conditions: Fronto-Temporal Dementia; Alzheimer Dementia; Parkinson Disease
• Interventions: Other: Eye-Tracking / Neuropsychological evaluations

• Registration Number: NCT04665622
• Lead Sponsor: Centre Hospitalier Princesse Grace

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-03-08
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Eye-Tracking / Neuropsychological evaluations	20 subjects
Parkinson's Disease	Eye-Tracking / Neuropsychological evaluations	20 subjects
Fronto-temporal Dementia	Eye-Tracking / Neuropsychological evaluations	10 subjects
Alzheimer's Dementia	Eye-Tracking / Neuropsychological evaluations	20 subjects

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.
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).
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.
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.

Trial Locations

Locations (1)

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco