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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04665622
Other study ID # EYE-EMPATH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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