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

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04637191
Collaborator
University of Copenhagen (Other), Max Planck Institute for Human Development (Other), Karolinska Institutet (Other), The Cleveland Clinic (Other), University of California, Los Angeles (Other), UMC Utrecht (Other), Harvard Medical School (HMS and HSDM) (Other), Keio University (Other), California Institute of Technology (Other)
163
Enrollment
1
Location
1
Arm
40.7
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: MentalPlus®
 N/A

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, 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
163 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®
Actual Study Start Date :
Jul 8, 2020
Anticipated Primary Completion Date :
Nov 29, 2022
Anticipated Study Completion Date :
Nov 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MentalPlus®

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®
A digital game named MentalPlus will be used to evaluate the possibility of this game becoming a neuropsychological test.
Other Names:
  • Digital Game

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language. [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Livia Stocco Sanches Valentin São Paulo SP Brazil 02019-010

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Livia S Valentin, Ph.D, University of Sao Paulo School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Livia Stocco Sanches Valentin, Professor, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT04637191
    Other Study ID Numbers:
    • USaoPaulo-I
    First Posted:
    Nov 19, 2020
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Livia Stocco Sanches Valentin, Professor, University of Sao Paulo
    Digital games
    Neuropsychology
    Hypertension

    Study Results

    No Results Posted as of Nov 19, 2020