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

March 8, 2022 updated by: Centre Hospitalier Princesse Grace

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Theory of mind during an artwork observation: Score 1
Time Frame: 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).
Baseline
Cognitive Theory of mind during an artwork observation: Score 2
Time Frame: 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).
Baseline
Cognitive Theory of mind: TOM-15 a false-belief task to assess cognitive theory of mind
Time Frame: 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.
Baseline
Affective ToM (Score 3)
Time Frame: 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.
Baseline
Affective ToM : The Reading the Mind in the Eye test - RME - (Baron-Cohen S at al., 2001)
Time Frame: 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.
Baseline
Affective empathy: Score 4.
Time Frame: Baseline
Intensity of the emotion felt by the participant following observation of the table, using an EVA scale [0-10].
Baseline
Affective empathy: The Empathy Quotient (EQ).
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Princesse Grace

Collaborators

Association de Recherche Bibliographique pour les Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

December 7, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYE-EMPATH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Eye-Tracking / Neuropsychological evaluations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe