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Clinical Trials/NCT04637191
NCT04637191
Completed
N/A

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

University of Sao Paulo1 site in 1 country163 target enrollmentJuly 8, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neuropsychological Test
Sponsor
University of Sao Paulo
Enrollment
163
Locations
1
Primary Endpoint
Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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, which limits routine use. Consequently, there is a limitation to adopting measures to increase preoperative cognitive reserve and rehabilitation of POCD. That situation incentivizes searching for alternative diagnosis methods to overcome that limitation. Digital games have potential neuromodulator effects and have been used as an alternative to psychotherapeutic treatment. However, the tests used to detect postoperative cognitive dysfunction (POCD) are time-consuming, making it difficult to implement routine screening measures. This presents a challenge for increasing preoperative cognitive reserve and rehabilitating POCD. Researchers are exploring alternative diagnostic methods, such as digital games, to address this challenge. Digital games have potential neuromodulator effects and are an alternative to psychotherapeutic treatments and cognitive rehabilitation. This study aims to validate MentalPlus®, a digital game, as a tool for cognitive assessment, POCD evaluation, and POCD rehabilitation-habilitation of mental skills. It is hypothesized that a digital game could replace the usual neuropsychological tests for detecting POCD.

Detailed Description

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, the volunteers assess cognitive functions, like memory, attention, and executive functions, using a usual psychological test battery. Compare the psychological test battery results with MentalPlus® video game scores. The MentalPlus® digital game will be applied to all study phases. A third project will use functional magnetic resonance imaging (fMRI) to assess the association between brain response and cognitive training by MentalPlus®.

Registry
clinicaltrials.gov
Start Date
July 8, 2020
End Date
November 29, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Livia Stocco Sanches Valentin

Professor

University of Sao Paulo

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language.

Time Frame: 1 year

Cognitive evaluation of 60 patients in the pre and postoperative period using the MentalPlus scale for the evaluation of postoperative cognitive dysfunction.

Study Sites (1)

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