Eye Gaze Strategies During Facial Emotion Recognition in Neurodegenerative Diseases: Links With Neuropsychiatric Disorders (EYE-ToM Study)

NCT ID: NCT04748263

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2020-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Dementia Parkinson Disease(PD) Fronto-Temporal Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fronto-Temporal Dementia (FTD)

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

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

Intervention Type OTHER

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)

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

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

Intervention Type OTHER

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.

Parkinson's Disease (PD)

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

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

Intervention Type OTHER

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.

Healthy volunteers

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

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

Intervention Type OTHER

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.

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association de Recherche Bibliographique pour les Neurosciences

OTHER

Sponsor Role collaborator

Centre Hospitalier Princesse Grace

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain PESCE, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

CH Princesse Grace

Sandrine LOUCHART de la CHAPELLE, MD

Role: PRINCIPAL_INVESTIGATOR

CH Princesse Grace

Other Identifiers

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15-05

Identifier Type: -

Identifier Source: org_study_id

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