Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease

Family Caregivers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267028
• Other study ID #: EYE-TAR(AD+)
• Status: Completed
• Start date: February 10, 2022
• Est. completion date: March 22, 2023

Study information

• Verified date: March 2023
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Dementia
• Family Caregivers

Intervention

Other:
• AD-TAR
12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using a rehabilitation program named Training of Affect Recognition (TAR).
• AD-Cognitive Stimulation
12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.

Locations

Country	Name	City	State
Monaco	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Centre Hospitalier Princesse Grace, Universite Cote d'Azur

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial emotion recognition (FER) performances	Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.; Evaluation criteria: Scores to Ekman Faces task (1976). FER was assessed using pictures from the Ekman Faces task (1976), to test the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral), with a maximum of 8 seconds of response time per picture.	Baseline; Week 6; 1 month post intervention
Primary	Facial emotion recognition (FER) performances (dynamic set)	Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.; Evaluation criteria: Scores to the Amsterdam Dynamic Facial Expression Set (ADFES).; FER was assessed using pictures from the Amsterdam Dynamic Facial Expression Set (ADFES/ Van Der Schalk J, Hawk ST, Fischer AH, Doosje B. Moving faces, looking places: validation of the Amsterdam Dynamic Facial Expression Set (ADFES). Emotion. 2011;11(4):907-20.), to test the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral), with a maximum of 8 seconds of response time per picture.	Baseline; Week 6; 1 month post intervention
Secondary	Facial emotion recognition (FER) performances - Response times	Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.; Evaluation criteria: Response times to identify pictures from the Ekman Faces task (1976).	Baseline; Week 6; 1 month post intervention
Secondary	Facial emotion recognition (FER) performances - Response times (dynamic set)	Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.; Evaluation criteria: Response time to identify dynamic expressions from the Amsterdam Dynamic Facial Expression Set (ADFES).	Baseline; Week 6; 1 month post intervention
Secondary	Eye movements behaviors during Facial emotion recognition (FER)	Change from Baseline and Comparison of gaze patterns between AD-TAR group and AD-Cognitive Stimulation group, during Facial emotion recognition tasks.; Evaluation criteria: Eye movements (number of fixations on areas of interest) recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).	Baseline; Week 6; 1 month post intervention
Secondary	Eye-Tracking Measurements during Facial emotion recognition (FER)	Change from Baseline and Comparison of gaze patterns between AD-TAR group and AD-Cognitive Stimulation group, during Facial emotion recognition tasks.; Evaluation criteria: Eye movements (duration of fixations on areas of interest) recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).	Baseline; Week 6; 1 month post intervention
Secondary	Eye gaze strategies during Facial emotion recognition (FER) (dynamic set)	Change from Baseline and Comparison of gaze patterns between AD-TAR group and AD-Cognitive Stimulation group, during Facial emotion recognition tasks.; Evaluation criteria: Eye movements (timeline of eye fixations on areas of interest) recorded with a gaze recording device Tobii. FER was assessed using some pictures from the Amsterdam Dynamic Facial Expression Set (ADFES - 2011).	Baseline; Week 6; 1 month post intervention
Secondary	Behavioral disorders	Change from Baseline and Comparison between AD-TAR group and AD-Cognitive Stimulation group, Evaluation criteria: Neuropsychiatric Inventory (NPI), a scale that includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). The evaluation was based on an interview with patients' primary caregivers. Both the frequency (/5) and the severity (/3) of each behavior were determined and a score was calculated by multiplying the frequency and the severity of each behavior observed during the last month.	Baseline; Week 6; 1 month post intervention
Secondary	The Family caregiver's burden	Change from Baseline and Comparison between AD-TAR group and AD-Cognitive Stimulation group, Evaluation criteria: The burden of the family caregiver was measured with the Zarit scale (completed by the caregiver). Composed of 22 questions on the physical, emotional and financial load felt. Total score /88.	Baseline; Week 6; 1 month post intervention
Secondary	Global cognitive performance	Change from Baseline and Comparison between AD-TAR group and AD-Cognitive Stimulation group, Evaluation criteria: MMSE (MINI MENTAL STATE EXAMINATION). 30-question general cognitive function assessment. The maximum score is 30.	Baseline; Week 6; 1 month post intervention