Clinical trial NCT04637191: Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®
Official title: Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropsychological Test
Keywords: Digital games
Neuropsychology
Hypertension
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Max Planck Institute for Human Development
name: Karolinska Institutet
name: The Cleveland Clinic
name: University of California, Los Angeles
name: UMC Utrecht
name: Harvard Medical School (HMS and HSDM)
name: Keio University
name: California Institute of Technology
First posted: 2020-11-19
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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®.

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.

Primary outcomes:
measure: Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Livia Stocco Sanches Valentin
state: SP
Study officials:
affiliation: University of Sao Paulo School of Medicine
name: Livia S Valentin, Ph.D
role: PRINCIPAL_INVESTIGATOR
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