Clinical trial NCT04730440: Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease
Official title: Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease and Study of the Consequences on Gaze Strategy, Behavior Disorders and Family Caregivers' Burden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Dementia
Family Caregivers
Keywords: Video-oculography
Eye-Tracking
Gaze strategies
Oculomotor behaviors
Training of Affect Recognition
Emotion recognition
Facial emotion recognition
Theory of Mind (ToM)
Behavioral disorders
Caregiver's burden
Alzheimer's Dementia
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
Collaborators: name: Association de Recherche Bibliographique pour les Neurosciences
name: Universite Cote d'Azur
First posted: 2021-01-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an Alzheimer's disease and with a Mini-Mental State score ≥15

Brief summary: This study aims to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition, on social cognition abilities in Alzheimer's disease (AD). In addition, we hypothesis that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.

Detailed description: 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, Alzheimer's Dementia (AD) and Parkinson's Disease, with severe deficits in FTD and lighter deficits in AD and PD. One explanation is that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others.

Our study aims to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition, on social cognition abilities (facial emotion recognition (FER) and theory of mind (ToM)) in Alzheimer's disease (AD). In addition, we hypothesis that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.

Eligibility criteria: Inclusion Criteria:

* AD diagnosed according to l'IWG-2 (Dubois \& al. 2014) criteria,
* Mini-Mental State (MMS-E) ≥15
* Subject accompanied by a family caregiver and whose participation in a cognitive stimulation workshop was recommended in Memory Centre of the RAINIER Centre (Princesses Grace Hospital - Monaco)
* Written informed consent signed by patient and family caregiver.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Ophthalmological or neurological 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 bipolar disorder or schizophrenia
* History of alcohol abuse.

Primary outcomes:
measure: Facial emotion recognition (FER) performances
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Affective ToM performances
timeFrame: Baseline; Week 6; 1 month post intervention
Secondary outcomes:
measure: Eye gaze strategies during Facial emotion recognition (FER)
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Behavioral disorders
timeFrame: Baseline; Week 6; 1 month post intervention
measure: The Family caregiver's burden
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Global cognitive performance
timeFrame: Baseline; Week 6; 1 month post intervention
Other outcomes:
Locations:
Study officials:
References: