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Completed

NCT Number: NCT04665622

Assessment of Empathetic Process by Scanpath Study of an Artwork

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

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Key information

Conditions

Alzheimer Dementia Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Fronto-Temporal Dementia Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Princesse Grace

Monaco, 98000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eye-Tracking / Neuropsychological evaluations

Other

Use of Eye-Tracking / Neuropsychological évaluations in 4 groups

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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].

  7. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Collaborators

  • Association de Recherche Bibliographique pour les Neurosciences

Registry information

Official study title

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

Acronym: EYE-EMPATH

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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