跳至主要内容
临床试验/NCT04637191
NCT04637191已完成不适用

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

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2020年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
163
试验地点
2
主要终点
Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language.

研究概览

简要总结

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.

详细描述

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®.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

MentalPlus®

Experimental

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.

干预措施: MentalPlus® (Device)

结局指标

主要结局

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

时间窗: 1 year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Livia Stocco Sanches Valentin

Professor

University of Sao Paulo

研究点 (2)

Loading locations...

相似试验