Long-term Follow-up of Patients Included in the EYE-TAR(MA) Study.
NCT ID: NCT05254873
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7 participants
OBSERVATIONAL
2022-01-21
2022-04-11
Brief Summary
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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
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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.
Because there is not long-term follow-up data for these patients, Sponsor and investigators set-up the EYE-TAR(MA)-Follow-Up study to evaluate the long-term impacts of the Training of Affect Recognition, on social cognition abilities, evolve gaze strategies, behavioral disorders, and the caregiver's burden.
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 a visit two years post EYE-TAR(MA) study intervention 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).
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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AD-TAR
AD subjects who took part to Facial Emotion Recognition rehabilitation (TAR) during EYE-TAR(MA) study
Long term follow-up
Long term follow-up for patient who completed the EYE-TAR(MA) study.
AD-Cognitive Stim
AD subjects who took part to cognitive stimulation session (12 sessions during 4 weeks) during EYE-TAR(MA) study
Long term follow-up
Long term follow-up for patient who completed the EYE-TAR(MA) study.
Interventions
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Long term follow-up
Long term follow-up for patient who completed the EYE-TAR(MA) study.
Eligibility Criteria
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Inclusion Criteria
* Subject accompanied by the caregiver already present during participation in the EYE-TAR (MA) study.
* Written informed consent signed by patient and family caregiver.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Princesse Grace
OTHER
Association de Recherche Bibliographique pour les Neurosciences
OTHER
Responsible Party
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Principal Investigators
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Sandrine LOUCHART DE LA CHAPELLE, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
Locations
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Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, , Monaco
Countries
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Related Links
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Polet K, \& al. 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. Neurol psychiatr gériatr, 2021 ; 21(12
Mirzai M, \& al. Long-term effects of rehabilitation of facial emotion recognition and its clinical consequences in Alzheimer's disease
Other Identifiers
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EYE-TAR(MA)-FU
Identifier Type: -
Identifier Source: org_study_id