Alzheimer DementiaEYE-TAR(MA)NCT04730440
Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease
An observational study of Alzheimer Dementia and Family Caregivers, run by Centre Hospitalier Princesse Grace.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Dementia, Family Caregivers
- What is being tested?
- AD-TAR and AD-Cognitive Stimulation
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 26 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an Alzheimer's disease and with a Mini-Mental State score ≥15
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer Dementia, Family Caregivers
- Being tested
- AD-TAR, AD-Cognitive Stimulation
- Keywords
- Video-oculography, Eye-Tracking, Gaze strategies, Oculomotor behaviors, Training of Affect Recognition, Emotion recognition, Facial emotion recognition, Theory of Mind (ToM), Behavioral disorders, Caregiver's burden, Alzheimer's Dementia
- Medical subject headings
- Alzheimer Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-TAROther
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 StimulationOther
Intervention description: 12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.
| Study group | Role | What they receive |
|---|---|---|
| AD-TAR | AD subjects who take part to Facial Emotion Recognition rehabilitation (TAR) Receives: Other: AD-TAR | |
| AD-Cognitive Stimulation | AD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks) Receives: Other: AD-Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Week 6; 1 month post intervention
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).
Measured: Baseline; Week 6; 1 month post intervention
Secondary outcomes (4)
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).
Measured: Baseline; Week 6; 1 month post intervention
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.
Measured: Baseline; Week 6; 1 month post intervention
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.
Measured: Baseline; Week 6; 1 month post intervention
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.
Measured: Baseline; Week 6; 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Mar 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Collaborators
- Association de Recherche Bibliographique pour les Neurosciences, Universite Cote d'Azur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730440
- Sponsor's protocol ID
- 19-02
- Acronym
- EYE-TAR(MA)
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04730440
- Acronym / sponsor ID
- EYE-TAR(MA) / 19-02
- Conditions
- Alzheimer Dementia, Family Caregivers
- Keywords
- Video-oculography, Eye-Tracking, Gaze strategies, Oculomotor behaviors, Training of Affect Recognition, Emotion recognition, Facial emotion recognition, Theory of Mind (ToM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Collaborators
- Association de Recherche Bibliographique pour les Neurosciences, Universite Cote d'Azur
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD-TAR | – | Other: AD-TARAD subjects who take part to Facial Emotion Recognition rehabilitation (TAR) |
| AD-Cognitive Stimulation | – | Other: AD-Cognitive StimulationAD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an Alzheimer's disease and with a Mini-Mental State score ≥15
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-TARIntervention 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). | Other | AD-TAR |
| AD-Cognitive StimulationIntervention description: 12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops. | Other | AD-Cognitive Stimulation |
Primary outcome
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.
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).
4 secondary outcomes
Eye gaze strategies during Facial emotion recognition (FER)
Time frame: Baseline; Week 6; 1 month post intervention
Behavioral disorders
Time frame: Baseline; Week 6; 1 month post intervention
The Family caregiver's burden
Time frame: Baseline; Week 6; 1 month post intervention
Global cognitive performance
Time frame: Baseline; Week 6; 1 month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- 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'aidantLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia and Family Caregivers, run by Centre Hospitalier Princesse Grace.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial emotion recognition (FER) performances (time frame: Baseline; Week 6; 1 month post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.