Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease (EYE-TAR(MA))

January 26, 2021 updated by: Centre Hospitalier Princesse Grace

Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease and Study of the Consequences on Gaze Strategy, Behavior Disorders and Family Caregivers' Burden

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with an Alzheimer's disease and with a Mini-Mental State score ≥15

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AD-TAR
AD subjects who take part to Facial Emotion Recognition rehabilitation (TAR)
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
AD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks)
Other: AD-Cognitive Stimulation
Intervention description: 12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial emotion recognition (FER) performances
Time Frame: Baseline; Week 6; 1 month post intervention

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
Affective ToM performances
Time Frame: Baseline; Week 6; 1 month post intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye gaze strategies during Facial emotion recognition (FER)
Time Frame: Baseline; Week 6; 1 month post intervention

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
Behavioral disorders
Time Frame: Baseline; Week 6; 1 month post intervention
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
The Family caregiver's burden
Time Frame: Baseline; Week 6; 1 month post intervention
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
Global cognitive performance
Time Frame: Baseline; Week 6; 1 month post intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Princesse Grace

Collaborators

Association de Recherche Bibliographique pour les Neurosciences
Universite Cote d'Azur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

March 26, 2020

Study Completion (ACTUAL)

March 26, 2020

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (ACTUAL)

January 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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