Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease

Alzheimer Dementia Clinical Trial

— EYE-TAR(MA)  

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: NCT04730440
• Other study ID #: 19-02
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: March 26, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Princesse Grace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Dementia
• Family Caregivers

Intervention

Other:
• AD-TAR
Intervention description: 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
Intervention description: 12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

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) and time to answer. 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	Affective ToM performances	Change from Baseline and Comparison of Affective ToM performance between AD-TAR group and AD-Cognitive Stimulation group.; Evaluation criteria: Scores to the " Reading the Mind in the Eyes " test (Baron-Cohen 2001). 36 black-and-white photographs of the eye area of faces. Subjets are asked to choose which word, among four options, best described what the character in the photograph was thinking or feeling. For this task, four scores were obtained: a total score (/36) and three emotional valence sub-scores: positive (/8), neutral (/16) and negative (/12).	Baseline; Week 6; 1 month post intervention
Secondary	Eye gaze strategies 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 and 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	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

External Links

•   Remédiation de la reconnaissance des émotions faciales dans la maladie d'Alzheimer et effets sur les stratégies d'observation, les troubles du comportement et le fardeau de l'aidant