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Completed

NCT Number: NCT05267028

Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Dementia (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Family Caregivers Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AD-TAR

Other

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

Other

12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.

Primary outcomes

  1. 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). 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.

  2. Facial emotion recognition (FER) performances (dynamic set)

    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 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.

Secondary outcomes

  1. Facial emotion recognition (FER) performances - Response times

    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: Response times to identify pictures from the Ekman Faces task (1976).

  2. Facial emotion recognition (FER) performances - Response times (dynamic set)

    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: Response time to identify dynamic expressions from the Amsterdam Dynamic Facial Expression Set (ADFES).

  3. Eye movements behaviors 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 of fixations on areas of interest) recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).

  4. Eye-Tracking Measurements 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 (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).

  5. Eye gaze strategies during Facial emotion recognition (FER) (dynamic set)

    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 (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).

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Association de Recherche Bibliographique pour les Neurosciences

Other

Collaborators

  • Centre Hospitalier Princesse Grace
  • Universite Cote d'Azur

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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