NCT04748263

Brief Summary

It is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (Theory of Mind), are associated with social behavior disorders. This kind of disorders are observed in Fronto-Temporal Dementia (FTD), Alzheimer's Dementia (AD) and Parkinson's Disease (PD), with severe deficits in FTD and lighter deficits in AD and PD. One explanation might be that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others. This study aims to test this hypothesis and further to analyse whether different patterns emerge from these pathologies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.4 years

First QC Date

January 26, 2021

Last Update Submit

February 5, 2021

Conditions

Keywords

Eye-TrackingNeuropsychological evaluations

Outcome Measures

Primary Outcomes (6)

  • Eye gaze strategies (number of eye fixation) during Affective Theory of Mind (ToM)

    Comparison of gaze patterns between control group and pathological groups, during Affective ToM task Evaluation criteria: number of eye fixation. Eye movements were recorded with an eye-tracking device. Affective ToM was assessed using the " Reading the Mind in the Eyes " test (Baron-Cohen 2001).

    Baseline

  • Eye gaze strategies (duration of eye fixations) during Affective Theory of Mind (ToM)

    Comparison of gaze patterns between control group and pathological groups, during Affective ToM task. Evaluation criteria: duration of eye fixations. Eye movements were recorded with an eye-tracking device. Affective ToM was assessed using the " Reading the Mind in the Eyes " test (Baron-Cohen 2001).

    Baseline

  • Eye gaze strategies (response times) during Affective Theory of Mind (ToM)

    Evaluation criteria: time to answer for each picture (in second). It was recorded using the eye-tracking device. Affective ToM was assessed using 36 pictures from the " Reading the Mind in the Eyes " test (Baron-Cohen 2001), with a maximum of 8 seconds of response time per picture.

    Baseline

  • Eye gaze strategies (number of eye fixation) during Facial emotion recognition (FER)

    Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: number of eye fixation. Eye movements were recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).

    Baseline

  • Eye gaze strategies (duration of eye fixation) during Facial emotion recognition (FER)

    Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: duration of eye fixations. Eye movements were recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).

    Baseline

  • Eye gaze strategies (response times) during Facial emotion recognition (FER)

    Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: time to answer for each picture (in second). It was recorded using the eye-tracking device. Facial emotion recognition was assessed using 28 pictures from The Ekman Faces task (1976), with a maximum of 8 seconds of response time per picture.

    Baseline

Secondary Outcomes (3)

  • Facial emotion recognition (FER) performances

    Baseline

  • Affective ToM performances

    Baseline

  • Behavioral disorders.

    Baseline

Study Arms (4)

Fronto-Temporal Dementia (FTD)

10 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.

Other: No intervention. Only survey and normal use of eye-tracking

Alzheimer's Dementia (AD)

20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.

Other: No intervention. Only survey and normal use of eye-tracking

Parkinson's Disease (PD)

20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.

Other: No intervention. Only survey and normal use of eye-tracking

Healthy volunteers

20 subjects Standard neuropsychological evaluations. Standard Eye-Tracking paradigms.

Other: No intervention. Only survey and normal use of eye-tracking

Interventions

The study is conducted in accordance with usual practices of eye-tracking and neuropsychological evaluations carried out at the Center Rainier III. Eye-Tracker® is used at the Centre Rainier III since August 2014. It is a non-invasive device for eye movements recording, allowing doctors and researchers to measure standard parameters related to eye movements. Developed by the Eye Brain Company (France), this is a Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE.

Alzheimer's Dementia (AD)Fronto-Temporal Dementia (FTD)Healthy volunteersParkinson's Disease (PD)

Eligibility Criteria

Age45 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient 45 years old and above healthy or with FTD, AD or PD pathology

You may qualify if:

  • Hospitalized or coming to perform a consultation, for whom an Eye-Tracking examination is indicated as part of routine care.
  • Sufficient written and oral expression in French.
  • Written informed consent signed by the patient.
  • For the control group: No cognitive impairment (non pathological MMSE (according to age, gender and socio-cultural level), no neurological history, and no psychiatric history (especially anxiety and depressive disorders).
  • For the FTD group: Patient diagnosed according to revised Rascovsky et al. 2011., no neurological history (excepted diagnosed FTD), and no psychiatric history (excepted those related to diagnosed FTD).
  • For the AD group: Patient diagnosed according to DSM-IV-TR criteria, no neurological history (excepted diagnosed AD), and no psychiatric history (excepted those related to diagnosed AD).
  • For the PD group: Patient diagnosed according to NINDS criteria, no neurological history (excepted diagnosed PD), and no psychiatric history (excepted those related to diagnosed PD).

You may not qualify if:

  • General anaesthesia within 3 months.
  • Ophthalmological problems preventing a video-oculography examination.
  • Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
  • Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
  • History of stroke.
  • History of alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseParkinson Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Officials

  • Alain PESCE, MD-PHD

    CH Princesse Grace

    PRINCIPAL INVESTIGATOR
  • Sandrine LOUCHART de la CHAPELLE, MD

    CH Princesse Grace

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 10, 2021

Study Start

July 1, 2015

Primary Completion

December 1, 2019

Study Completion

November 1, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share