Assessment of Empathetic Process by Scanpath Study of an Artwork

Parkinson Disease Clinical Trial

— EYE-EMPATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665622
• Other study ID #: EYE-EMPATH
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Princesse Grace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Fronto-Temporal Dementia
• Frontotemporal Dementia
• Parkinson Disease
• Pick Disease of the Brain

Intervention

Other:
• Eye-Tracking / Neuropsychological evaluations
Use of Eye-Tracking / Neuropsychological évaluations in 4 groups

Locations

Country	Name	City	State
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Princesse Grace	Association de Recherche Bibliographique pour les Neurosciences

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Primary	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.	Baseline
Primary	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.	Baseline
Secondary	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).	Baseline
Secondary	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).	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	Affective empathy: Score 4.	Intensity of the emotion felt by the participant following observation of the table, using an EVA scale [0-10].	Baseline
Secondary	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.	Baseline