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- Essai clinique NCT02337439
Perceptual Deficits in Schizophrenia
Cognitive Remediation for Perceptual Deficits in Schizophrenia
In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises.
The study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. Some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. The disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. Current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. Computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. Our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training.
In this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Connecticut
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New Haven, Connecticut, États-Unis, 06511
- Yale University School Of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- schizophrenia or schizoaffective disorder
- English speaking and reading
Exclusion Criteria:
- current substance abuse
- visual impairment
- neurological conditions
- current enrollment in another research study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sensory Information Processing Training
Computerized training designed to improve sensory processing
|
Computer exercises requiring identification of visual stimuli on computer screen and response with keyboard
|
|
Comparateur actif: Active Control Training
Commercially available computer exercises that were not designed specifically to improve sensory information processing.
|
Commercially available educational software
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive test performance
Délai: up to 6 months
|
Neuropsychological testing
|
up to 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Psychiatric symptoms
Délai: up to 6 months
|
Clinical interviews and ratings
|
up to 6 months
|
|
Social Functioning
Délai: up to 6 months
|
Clinical rating scales
|
up to 6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
- Tandon R, Keshavan MS, Nasrallah HA. Schizophrenia, "just the facts" what we know in 2008. 2. Epidemiology and etiology. Schizophr Res. 2008 Jul;102(1-3):1-18. doi: 10.1016/j.schres.2008.04.011. Epub 2008 Jun 2.
- Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
- Carpenter WT, Buchanan RW. Lessons to take home from CATIE. Psychiatr Serv. 2008 May;59(5):523-5. doi: 10.1176/ps.2008.59.5.523.
- Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
- Surti TS, Wexler BE. A pilot and feasibility study of computer-based training for visual processing deficits in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):248-9. doi: 10.1016/j.schres.2012.09.013. Epub 2012 Oct 6. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
- V1CDA2013-24
- 01856 (Autre identifiant: VACHS IRB)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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