Digital Game: A Scale to Evaluate the Perioperative Cognitive Function (MentalPlus®)

March 5, 2024 updated by: Livia Stocco Sanches Valentin, University of Sao Paulo

Digital Game MentalPlus®: A Scale to Evaluate on Perioperative Cognitive Function: Content Analysis, Internal Consistency, Convergent Validity and Clinical Validation of the Diagnostic Test

INTRODUCTION: 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 are time-consuming and with variable sensitivity and specificity and difficult routine use. Applying a difficult battery of cognitive tests decreases the viability of adopting measures to increase preoperative cognitive reserve and methods for prevention, diagnosis and rehabilitation of cases of Postoperative Cognitive Dysfunction (POCD), it is desirable to search for alternative methods diagnoses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thinking about this concern, the investigators created a digital game to assess quickly and funny the cognitive functions (memory; attention and executive). The investigators know that 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 can replace the commonly used neuropsychological tests for detecting postoperative cognitive dysfunction. The aim of this study is to validate a specific digital game (MentalPlus®) for cognitive assessment and evaluation of its use for detecting of postoperative cognitive dysfunction.

METHODS: The participants will be studied over 20 years old, literate, of both genders and candidates for surgery under general anesthesia in the Clinics Hospital of the Faculty of Medicine, University of São Paulo. Will also be applied neuropsychological tests to evaluate memory, attention, and executive functions as well as another tests to assess specifics contents useful to describe the sample and research' results. The tests applied will be on specific data set. In another study the investigators will include volunteers to assess short and long term memory Verbal Learnings Test (VLT), visual memory with Recognition Memory Test (TEM-R), to executive functions with STROOP Test and the selective and alternating attention with Trail Making Test (TMT-A / B). For Quality of Life the investigators will use the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI) to assess depressive and anxiety symptoms, beyond of the MentalPlus®. In a third project the investigators will use functional magnetic resonance imaging (fMRI) to assess the association between brain response and cognitive training by MentalPlus®. Reliability analysis will be performed and the validity of the digital game will be assessed in terms of evaluation of cognitive functions in a fun and practical way and this may provide health professionals, including anesthesiologists and surgeons with a new method for neuropsychological evaluation.

Detail description about the neuropsychological tests and scales: Sociodemographic data will be analyzed including education, marital status, occupation, and current medication. Signs and symptoms of depression will be assess preoperatively using the Beck Depression Inventory (BDI), for screening on global cognitive will be use Telephone Interview for Cognitive Status (TICS), will be use the Verbal Learning Test (VLT) for long-term memory and the Recognition Memory Test (TEM-R) for visual memory, the Symbol Digit Modified Test (SDMT) will be use to assess short-term memory, visual search skill and attention, STROOP Test will be assess the selective attention, inhibitory ability and mental flexibility that are constructs of executive function and the Trail Making Test (TMT) for the assessment of selective and alternating attention.

Beck Depression Inventory (BDI), which consists of 21 questions that explore depressive symptoms on a scale of 0 to 4, where zero represents no symptoms and four is the maximum symptomatology. A total of 14 points will be consider indicative of the presence of moderate depressive symptoms22.

Patient Questionnaire health (PHQ-9), this questionnaire about the health of the patient is an instrument with 9 questions. Each question has 4 possible responses: 0 (no day), 1 (several days), 2 (more than half days), and 3 (nearly every day). The PHQ-9 can be interpreted in three ways: 10 in the form of algorithm, identifying individuals with a major depressive episode and tracking probable cases of major depressive disorder; 20 as a continuous measure, with scores between 0 and 27 points, being able to assess levels of depressive symptoms through the cut- points 5, 10, 15 and 20 points = mild depression, moderate, severe and serious; 30 as continuous measurements with scores between 0 and 27 points, classifying the individuals dichotomous through the use of a single cutting point (typically ≥10).

The Telephone Interview for Cognitive Status (TICS) will be use as a standardized test to assess neuropsychological functioning when assessing cognitive skills. This test can be used when screening personally is impractical or when patients are unable to attend the clinic. This test consists of a structured interview with 11 items that assess the skills of spatial and temporal orientation, mental control, memory, general information, language and calculations.

Memory will be assessed using the Verbal Learning Test (VLT) this test consists of a list of words. A list of 15 words is presented and must to be stored and recalled in three successive attempts (VLT / A-B-C), with delayed recall after 25 minutes (VLT-Delay). Rate is the number of words recalled and the number of errors for each presentation. The VLT evaluates the modalities of memory immediate, consolidated and long-term. This instrument will be held in two stages: pre-operative at the time of 1st evaluation before surgery and postoperatively in the second and final assessment between day 10 and 15 postoperatively.

The Recognition Memory Test (TEM-R) consists of storing pictures and words to further identify remembered stimuli. For the stimulus responses can be presented to the subject in graphic form (figures) or written (words). This instrument will be held in two stages: pre-operative at the time of 1st evaluation before surgery and postoperatively in the second and final assessment between day 10 and 15 postoperatively.

The Symbol Digit Modified Test (SDMT) will be applied for the evaluation of short-term memory, visual search skill and attention. This is a graphical task where the individual has to fill in symbols exemplified in the spaces below the corresponding number within 180 seconds. The result is measured as the number of symbols drawn and the number of errors.

Attention will be assessed by STROOP Test, which consists in presenting three paper sheets to the subject. The first one, the patient should verbalize the names of colors printed in black ink. In the second, verbalization is made of color are filled rectangles, the same provision of the words of the previous slide. The third blade consist in verbalize colors printed over the written word. Evaluates selective attention, inhibitory ability and mental flexibility that are constructs of executive function. Scores obtained include the number of words (Word task), number of bar colors (Color), and number of color words (Color-Word) completed within a set time, or as noted above, the amount of time required to complete each of the tasks. We will consider the number of errors as well.

Attention will also be evaluated using the Trail Making Test (TMT) for the assessment of selective and alternating attention. In part A of the test, the subject must draw lines connecting consecutively numbered circles. In part B, the subject must draw lines connecting circles alternately with letters and numbers in a sequence. The result is measured as time and trail errors. The Attention function will be examined with Trail Making Test (TMT). This test consists of two parts. In Part A, the subject must draw lines connecting consecutively numbered circles. In Part B, the subject must draw lines alternately connecting circles with letters and numbers in a sequence. The test involves addition of alternate and selective attention, visual screening and complex manual dexterity (Part A) and executive processes (Part B). Among the executive procedures, the inhibitory ability and cognitive alternating seem to be those most required in completing the task. They are valued the time spent and the number of errors in each of. These instrument will be held in two stages: pre-operative at the time of 1st evaluation before surgery and postoperatively in the second and final assessment between day 10 and 15 postoperatively.

About the scale for validation: the study will be guided on the validation of a digital game MentalPlus® in the form of scale to assess the neuropsychological functions: attention, memory, and executive. This scale will be measured with scores ranging between 0 and 20 to corrects and errors. Attention function: 0 (zero) corresponds to much trouble (too many errors); twenty (20) corresponds full capacity (correct total).

For the executive function will be assessed: capacity of resistance for distractor factor being measured by how much that person touches the tablet's screen in order to demonstrate the failure of inhibitory control of the actions. Scores between 0 and 20 where 0 (zero) means great inhibitory control up to twenty (20) total inability to inhibitory control.

For the memory function will be assessed the long-term memory, working memory and short-term visual memory. The scores for this function range from 0 to 20, with 0 (zero) total memorizing inability to long-term task and twenty (20) total long-term storage capacity evaluated after 25 minutes of exposure of the figures to be memorized. For the working memory will be exposed 7 icons to be mentioned over the next five minutes of exposure. Seven (7)= good ability to manipulate information in short-term time and 0 (zero) inability to store and manipulate information in short time.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 02019010
        • Livia Stocco Sanches Valentin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be a candidate for elective surgery small and medium-sized under general anesthesia for any surgical specialty. Have at least nine years of schooling or more, have between 20 and 40 years and want to participate in the research of their own free will.
  • diagnosis of Hypertension of Pressure Normal (HPN), the absence of malignancy, well-controlled clinical comorbidities (hypertension, diabetes mellitus, hormonal disorders, etc.) with predictive tools of post surgery results: tap test, lumbar infusion test, and continuous 72-hours external lumbar drainage and pressure monitoring.

Exclusion Criteria:

  • Provide a history of psychiatric disorders and dementias that affect cognition, lack of knowledge of the Portuguese language, use metal clips or cardiac pacemaker that preclude the examination by Functional Magnetic Resonance Imaging.
  • diagnosis of secondary HPN, inability to walk, malignancy, clinical comorbidities uncontrolled presenting a history of psychiatric disorders and dementias that affect cognition, for instance Alzheimer's Dementia, lack of knowledge of the Portuguese language, use metal clips or marked heart step, which makes the examination by Functional Magnetic Resonance Imaging no functionality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MentalPlus® PILOT-I
This preliminary group will be submitted to the digital game MentalPlus®, also be the submitted to fMRI before and after surgery. The results of standardized tests and the data of the MentalPlus® of patients undergoing surgery will be compared with the results of the same tests and the data of the MentalPlus® of healthy volunteers with similar characteristics regarding the variables age and education.
Device: MentalPlus®
Validate the MentalPlus® digital game as neuropsychological test of cognitive assessment pre and postoperative on study the internal consistency and validity of content and construct (convergent) MentalPlus® of the evaluated patients. Study the influence of age, gender and level of education of surgical patients in performance for the use of electronic devices (laptop, tablet, mobile) and digital games. Investigate the rehabilitation capacity of cognitive functions after training sessions with MentalPlus® game. Evaluate the effect of training with MentalPlus® game in brain networks involved in executive function, memory and attention by means of fMRI this is a brain imaging study.
Other Names:
  • Brazilian National Library Foundation nº 663707
Experimental: MentalPlus® PILOT-II
This preliminary group will be of healthy volunteers submitted to the digital game MentalPlus®. The results of standardized tests and the data of the MentalPlus® of volunteers will be compared with the results of tests of patients undergoing surgery and the data of the MentalPlus®.
Device: MentalPlus®
Validate the MentalPlus® digital game as neuropsychological test of cognitive assessment pre and postoperative on study the internal consistency and validity of content and construct (convergent) MentalPlus® of the evaluated patients. Study the influence of age, gender and level of education of surgical patients in performance for the use of electronic devices (laptop, tablet, mobile) and digital games. Investigate the rehabilitation capacity of cognitive functions after training sessions with MentalPlus® game. Evaluate the effect of training with MentalPlus® game in brain networks involved in executive function, memory and attention by means of fMRI this is a brain imaging study.
Other Names:
  • Brazilian National Library Foundation nº 663707
Active Comparator: Group I: MentalPlus®
Evaluated with neuropsychological tests and MentalPlus® before surgery. After surgery, from the 3rd postoperative day a tablet will be use with MentalPlus® in 7 versions for cognitive training during 7 days (7 versions with interfaces adapted for ages up to 20 years and 7 versions for ages over it).
Device: MentalPlus®
Validate the MentalPlus® digital game as neuropsychological test of cognitive assessment pre and postoperative on study the internal consistency and validity of content and construct (convergent) MentalPlus® of the evaluated patients. Study the influence of age, gender and level of education of surgical patients in performance for the use of electronic devices (laptop, tablet, mobile) and digital games. Investigate the rehabilitation capacity of cognitive functions after training sessions with MentalPlus® game. Evaluate the effect of training with MentalPlus® game in brain networks involved in executive function, memory and attention by means of fMRI this is a brain imaging study.
Other Names:
  • Brazilian National Library Foundation nº 663707
Sham Comparator: Group II: MentalPlus®
Ratings with neuropsychological testing and evaluation with MentalPlus® before surgery will be realized. After surgery, from the 3rd postoperative day a tablet will be use for entertainment with short films (20 minutes) for use in the placebo effect of digital game MentalPlus® this group also will be submitted to fMRI before and after surgery. (With the intention to respond to the specificity of findings in relation to the control for active placebo effect)
Device: MentalPlus®
Validate the MentalPlus® digital game as neuropsychological test of cognitive assessment pre and postoperative on study the internal consistency and validity of content and construct (convergent) MentalPlus® of the evaluated patients. Study the influence of age, gender and level of education of surgical patients in performance for the use of electronic devices (laptop, tablet, mobile) and digital games. Investigate the rehabilitation capacity of cognitive functions after training sessions with MentalPlus® game. Evaluate the effect of training with MentalPlus® game in brain networks involved in executive function, memory and attention by means of fMRI this is a brain imaging study.
Other Names:
  • Brazilian National Library Foundation nº 663707

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of cognitive functions: executive, memory and attention on the MentalPlus® Scale
Time Frame: 20 minutes
Scores range from 0 [Not improved] to 10 [fully improved] at cognitive functions memory, attention and executive after training with MentalPlus® Scale and compared with neuropsychological tests validated and standardised to the global population.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Neuropsychological Scores on the MentalPlus® Scale for memory, attention and executive function at 20 days.
Time Frame: 20 days
Scores range from 0 [Not improved] to 10 [fully improved] at cognitive functions memory, attention and executive after training with MentalPlus® Scale.
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Harvard Medical School (HMS and HSDM)
University of Copenhagen
Fundação de Amparo à Pesquisa do Estado de São Paulo
Max Planck Institute for Human Development

Investigators

  • Principal Investigator: Lívia SS Valentin, Ph.D., Faculty of Medicine of the University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Actual)

July 4, 2022

Study Completion (Actual)

October 29, 2023

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimated)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional Study Design

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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