Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®

Study Overview
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Brief Summary
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Cognitive dysfunction is a frequent adverse event in the postoperative period, especially in elderly patients. The tests commonly used for the detection of postoperative cognitive dysfunction (POCD) are time-consuming what limits their routine use. Consequently; there is a limitation to adopt measures to increase preoperative cognitive reserve and rehabilitation of POCD. That situation is an incentive to search for alternative diagnosis methods to overcome that limitation. Digital games have potential neuromodulator effect and have been used as an alternative to the psychotherapeutic treatment and rehabilitation of cognitive skills. However, the experience with these games to assess the integrity of perioperative neuropsychological functions is still scarce. It is hypothesized that a digital game could replace the usual neuropsychological tests for detecting POCD. The aim of this study is to validate a specific digital game, MentalPlus®, for cognitive assessment and POCD evaluation and for POCD rehabilitation.

Detailed Description
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METHODS: The research subject that will be studied might present some characteristics: over 20 years old, literate, of both genders and candidate for surgery under general anesthesia in the Hospital das Clínicas of the Faculty of Medicine, University of São Paulo. Reliability MentalPlus® analysis will be performed as the first part of the study with healthy volunteers. Later, in another study phase, we will include volunteers to assess cognitive functions, like memory, attention, and executive functions, using a usual psychological test battery. We will compare the psychological test battery results with MentalPlus® video game scores. The MentalPlus® digital game will be applied to all study phases. In a third project, we will use functional magnetic resonance imaging (fMRI) to assess the association between brain response and cognitive training by MentalPlus®. The main purpose is to have a new tool that can provide health professionals, including anesthesiologists and surgeons with a fun and practical way to evaluate cognition.

Official Title
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Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®

Conditions
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Neuropsychological Test

Intervention / Treatment
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* Device: MentalPlus®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who accept the invitation will be first submitted to the TICS Instrument (Telephone Interview Cognitive Status), which aims to verify the global cognitive status of the subject evaluated. Will be included subjects with TICS score >25. Exclusion Criteria: Patients who do not meet the TICS inclusion criteria will be excluded at this stage and informed that they did not fulfill all the requirements for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MentalPlus®<br>This group performed the task in the digital game for 25 minutes and later will be evaluated with standardized and validated neuropsychological tests for the studied population. | Device: MentalPlus®<br>* A digital game named MentalPlus will be used to evaluate the possibility of this game becoming a neuropsychological test.<br>* Other names: Digital Game;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language. | Cognitive evaluation of 60 patients in the pre and postoperative period using the MentalPlus scale for the evaluation of postoperative cognitive dysfunction. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital games, Neuropsychology, Hypertension