Clinical trial NCT05267028: 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's Dementia (AD)
Family Caregivers
Keywords: Facial emotion recognition
Training of Affect Recognition
Behavioral disorders
Caregiver's burden
Alzheimer's Dementia
Gaze strategies
Eye-Tracking
Oculomotor behaviors
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
name: Universite Cote d'Azur
First posted: 2022-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed at the Memory Center of the Rainier III Center, presenting a neurodegenerative pathology of the AD type, for whom participation in workshops (remediation of the recognition of facial emotions and cognitive stimulation) led by a neuropsychologist, is recommended.

Brief summary: EYE-TAR(AD+) is an observational study based on the same design as the princeps EYE-TAR(MA) study, but with a larger number of patients and including an additional evaluation of Facial emotion recognition (based on a more ecological material), in order to reinforce conclusions of the study EYE-TAR(MA) https://doi.org/10.1016/j.npg.2020.08.003.

The main objective is to confirm that facial emotion recognition can be improved in AD using the "Training of Affect Recognition program" (TAR).

The Secondary Objectives are to:

Evaluate the impact of the "Training of Affect Recognition program" (TAR) on oculomotor behavior in a situation of social cognition, on behavioral disorders and on caregiver burden.

Confirm that improvement in facial emotion recognition is related to modification of observation strategies.

Confirm the link between improved recognition of facial emotions, reduced behavioral disorders and caregiver burden.


Eligibility criteria: Inclusion Criteria:

* Male or Female.
* 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.
* History of psychiatric and/or neurological disorder (other than the diagnosed neurodegenerative pathology);
* History of alcoholism or drug addiction
* Ophthalmological or neurological problems preventing a video-oculography examination.
* Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
* Cognitive disorders of the neurovisual type (visual agnosia, prosopagnosia, visuo-spatial disorder or visuo-perceptual disorder) or aphasia.

Primary outcomes:
measure: Facial emotion recognition (FER) performances
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Facial emotion recognition (FER) performances (dynamic set)
timeFrame: Baseline; Week 6; 1 month post intervention
Secondary outcomes:
measure: Facial emotion recognition (FER) performances - Response times
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Facial emotion recognition (FER) performances - Response times (dynamic set)
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Eye movements behaviors during Facial emotion recognition (FER)
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Eye-Tracking Measurements during Facial emotion recognition (FER)
timeFrame: Baseline; Week 6; 1 month post intervention
measure: Eye gaze strategies during Facial emotion recognition (FER) (dynamic set)
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:
city: Monaco
country: Monaco
facility: Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Study officials:
affiliation: Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
name: Sandrine LOUCHART DE LA CHAPELLE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: