Digital Game: A Scale to Evaluate the Perioperative Cognitive Function

Cognition Disorders Clinical Trial

— MentalPlus®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551952
• Other study ID #: Interventional Study Design
• Status: Completed
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: October 29, 2023

Study information

• Verified date: March 2024
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: October 29, 2023
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Impaired Cognition
• Self-Assessment

Intervention

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.

Locations

Country	Name	City	State
Brazil	Livia Stocco Sanches Valentin	Sao Paulo

Sponsors (5)

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

Country where clinical trial is conducted

Brazil, 

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of cognitive functions: executive, memory and attention on the MentalPlus® Scale	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	Change From Baseline in Neuropsychological Scores on the MentalPlus® Scale for memory, attention and executive function at 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