- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02632604
Computerized Cognitive Training for the Elderly
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.
The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.
The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.
The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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RJ
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Rio de Janeiro, RJ, Brésil, 21941590
- Recrutement
- Federal University of Rio de Janeiro
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Contact:
- Linda Scoriels, Ph.D.
- Numéro de téléphone: +552139385588
- E-mail: lindascor@yahoo.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;
Exclusion Criteria:
- Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Bottom-up to top-down cognitive training
Participants are given 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes
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40 hours of a computerized cognitive training, given 1 hour daily
Autres noms:
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Comparateur actif: Top-down to bottom-up cognitive training
Participants are given 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes
|
40 hours of a computerized cognitive training, given 1 hour daily
Autres noms:
|
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Comparateur placebo: Computer games
Participants are given 40 hours of computer games commonly found on the internet and which do not involve a high demand in cognitive functions (e.g.
fishing game, pinball game, tetris, etc).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Global cognition score change
Délai: through study completion, an average of 1 year
|
An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline
|
through study completion, an average of 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Processing speed score change
Délai: through study completion, an average of 1 year
|
Processing speed score will be measured using the identification task from Cogstate tests battery
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through study completion, an average of 1 year
|
|
Attention score change
Délai: through study completion, an average of 1 year
|
Attention score will be measured using the detection task from Cogstate tests battery
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through study completion, an average of 1 year
|
|
Concentration score change
Délai: through study completion, an average of 1 year
|
Concentration score will be measured using the Trail Making Test
|
through study completion, an average of 1 year
|
|
Short-term memory score change
Délai: through study completion, an average of 1 year
|
Short- term memory score will be measured using the Rey Auditory-Verbal learning test
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through study completion, an average of 1 year
|
|
long-term memory score change
Délai: through study completion, an average of 1 year
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long- term memory score will be measured using the Rey Auditory-Verbal learning test
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through study completion, an average of 1 year
|
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learning score change
Délai: through study completion, an average of 1 year
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learning score will be measured using the Rey Auditory-Verbal learning test
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through study completion, an average of 1 year
|
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working memory score change
Délai: through study completion, an average of 1 year
|
working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery
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through study completion, an average of 1 year
|
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Semantic memory score change
Délai: through study completion, an average of 1 year
|
semantic memory score will be measured using the Verbal fluency test
|
through study completion, an average of 1 year
|
|
Cognitive flexibility score change
Délai: through study completion, an average of 1 year
|
Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery
|
through study completion, an average of 1 year
|
|
social cognition score change
Délai: through study completion, an average of 1 year
|
Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery
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through study completion, an average of 1 year
|
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Depression score change
Délai: through study completion, an average of 1 year
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Depression score will be measured using the Geriatric Depression Scale
|
through study completion, an average of 1 year
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Instrumental activity of daily living score change
Délai: through study completion, an average of 1 year
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Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale
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through study completion, an average of 1 year
|
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Independence in activities of daily living score change
Délai: through study completion, an average of 1 year
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Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale
|
through study completion, an average of 1 year
|
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Functional status score change
Délai: through study completion, an average of 1 year
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Functional status score will be measured using the Direct Assessment of Functional Status questionnaire
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through study completion, an average of 1 year
|
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Timed instrumental activities of daily living score change
Délai: through study completion, an average of 1 year
|
Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale
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through study completion, an average of 1 year
|
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Physical activity score change
Délai: through study completion, an average of 1 year
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Physical activity score will be measured using the International Physical Activity Questionnaire
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through study completion, an average of 1 year
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Praxis score change
Délai: through study completion, an average of 1 year
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Praxis score will be measured using the Cambridge Cognition Examination test
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through study completion, an average of 1 year
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Episodic memory score change
Délai: through study completion, an average of 1 year
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Episodic memory score will be measured using the Cambridge Cognition Examination test
|
through study completion, an average of 1 year
|
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Quality of life score change
Délai: through study completion, an average of 1 year
|
Quality of life will be assessed with the World Health Organization Quality of Life questionnaire
|
through study completion, an average of 1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rogério Panizzutti, M.D, PhD, Universidade Federal do Rio de Janeiro
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
Autres numéros d'identification d'étude
- 110.180/2013
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