- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02874482
Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia (SAILLANCE1)
Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia
Background:
Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).
The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.
Main aim:
The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.
Secondary objectives:
To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.
To separate an explicit response (motors responses) with an implicit response (eye tracking measures).
Methodology:
30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study will include one visit:
- Written consent will be obtained from all participants
- Inclusion and exclusion criteria will be checked
- An ophthalmologic test, a pregnancy test, a alcohol test and a salivary test will be realized
- Various symptoms will be assessed with the PANSS (Positive And Negative Syndrome Scale for schizophrenia) and the UPDRS (Unified Parkinson Disease Rating Scale for patients, the MOCA (Montreal Cognitive Assessment), The HAD (Hospital Anxiety and Depression Scale) and the MINI (Mini International Neuropsychiatric Interview) for all participants.
- The task will be divided in two parts:
A visuo-spatial task allowing to record saccadic eye movements (approximately 10 min).
The change blindness session lasted approximately 20 min.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Lille, France, 59037
- University Hospital, Lille
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Normal or corrected vision
- Affiliate to a social security system
- For group of patients with schizophrenia : diagnosis of schizophrenia based on the standard DSM-IV criteria and patients will be clinically stable at the testing time
Exclusion Criteria:
- History of neurological illness
- Pregnant and nursing women
- Drugs use in the last 24 hours
- Acute ocular disorder
- Under tutorship, curatorship or deprived of liberty
- For controls group : be free DSM-IV axis-I diagnoses according the MINI test.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Patients with schizophrenia
30 patients with schizophrenia (diagnosis based on the standard DSM criteria)
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Contrôles
30 témoins sains sans aucun diagnostic psychiatrique ou neurologique
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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response time
Délai: 42 months
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The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.
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42 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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sensitivity index
Délai: 42 months
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Performances will be measure by a sensitivity index (D prime) which considers the number of correct detections compared with the missed detections and false alarms; thus it evaluates the capacity to discriminate the signal against a background noise.
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42 months
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implicit response
Délai: 42 months
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The implicit response will be measure by the localization and duration of fixations
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42 months
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emotional response
Délai: 42 months
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The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli
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42 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Guillaume VAIVA, University Hospital, Lille
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2013_19.1
- 2013-A01497-38 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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