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

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.

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Key information

Conditions

Neuropsychological Test Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Livia Stocco Sanches Valentin

São Paulo, 02019-010, Brazil

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MentalPlus®

Device

A digital game named MentalPlus will be used to evaluate the possibility of this game becoming a neuropsychological test.

Other names: Digital Game

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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

California Institute of Technology
Harvard Medical School (HMS and HSDM)
Karolinska Institutet
Keio University
Max Planck Institute for Human Development
The Cleveland Clinic
UMC Utrecht
University of California, Los Angeles
University of Copenhagen

Registry information

Acronym: MentalPlus®

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Nov 19, 2020
Registry last updated: Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed