Long-term Follow-up of Patients Included in the EYE-TAR(MA) Study: Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease and Study of the Consequences on Gaze Strategy, Behavior Disorders and Family Caregivers' Burden
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Facial emotion recognition (FER) performances
Study Overview
Brief Summary
EYE-TAR(MA)-Follow-Up is a non-interventionel, long-term follow-up study in subjects who participated to the study referred as EYE-TAR(MA) (NCT04730440)
EYE-TAR(MA)-Follow-Up aims to evaluate the long-term impacts of the Training of Affect Recognition TAR (an emotion recognition rehabilitation program), on social cognition abilities, evolve gaze strategies, behavioral disorders, and the caregiver's burden in Alzheimer's disease (AD).
Subjects who completed EYE-TAR(MA) study, and who have signed informed consent for this follow-up, will be eligible to enroll. They will attend one visit two years post EYE-TAR(MA) study intervention (intervention was TAR, or a "classic" cognitive stimulation program) to undergo the following evaluation: Eye-tracking recording during Ekman Faces task, Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Zarit scale (completed by caregiver).
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 (FTD), Alzheimer's Dementia (AD) and Parkinson's Disease (PD), 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.
The study EYE-TAR(MA), NCT04730440, aimed to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition (TAR), on social cognition abilities (facial emotion recognition and theory of mind) in AD. In addition, investigators hypothesized that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.
EYE-TAR(MA) results showed that participants who participated to the TAR (a) recognized facial emotions better and faster, especially sadness, fear and neutral expression; (b) evolved their gaze strategies on emotional faces with increased observation of the upper part of the face (nose and / or eyes); (c) had reduced behavioral disorders and the caregiver's burden. These results were specific to the TAR, since no significant change was observed in the AD-Control group who had participated in a "classic" cognitive stimulation program.
These changes were generally maintained one month after treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who were included in the EYE-TAR (MA) study, and who completed this study.
- •Subject accompanied by the caregiver already present during participation in the EYE-TAR (MA) study.
- •Written informed consent signed by patient and family caregiver.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Facial emotion recognition (FER) performances
Time Frame: 2 years follow-up
Change from EYE-TAR(MA) Last evaluation and Comparison of FER performance between Long-term follow-up AD-TAR group and Long-term follow-up 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.
Secondary Outcomes
- Behavioral disorders(2 years follow-up)
- The Family caregiver's burden(2 years follow-up)
- Eye gaze strategies during Facial emotion recognition (FER)(2 years follow-up)