Cognition DisordersMentalPlus®NCT02551952
Digital Game: A Scale to Evaluate the Perioperative Cognitive Function
A study testing MentalPlus® in people with Cognition Disorders and Impaired Cognition, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders, Impaired Cognition, Self-Assessment
- What is being tested?
- MentalPlus®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jul 2021to 29 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cognition Disorders, Impaired Cognition, Self-Assessment
- Being tested
- MentalPlus®
- Keywords
- Games, Cognitive Tests, General Anesthesia, Surgery
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentalPlus®Device
Also called Brazilian National Library Foundation nº 663707
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.
| Study group | Role | What they receive |
|---|---|---|
| MentalPlus® PILOT-I | Experimental | 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. Receives: Device: MentalPlus® |
| MentalPlus® PILOT-II | Experimental | 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®. Receives: Device: MentalPlus® |
| Group I: MentalPlus® | Active comparator | 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). Receives: Device: MentalPlus® |
| Group II: MentalPlus® | Sham comparator | 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) Receives: Device: MentalPlus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (1)
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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start8 Jul 2021
- Primary completion4 Jul 2022
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conceived as a randomized, double-blind exploratory trial. It received the approval of the Ethics Committee for Research Project Analysis (CAPPesq) of the Clinical Board, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Copenhagen, Harvard Medical School (HMS and HSDM), Max Planck Institute for Human Development
- Responsible party
- Principal investigator, Livia Stocco Sanches Valentin, University of Sao Paulo
- Investigators
- Lívia SS Valentin, Ph.D., Principal investigator, Faculty of Medicine of the University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551952
- Sponsor's protocol ID
- Interventional Study Design
- Acronym
- MentalPlus®
- Status last verified
- Mar 2024
- First submitted
- 31 Aug 2015
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Hyde TF, Reddy DM, Hudetz AG, Warltier DC. Postoperative cognitive dysfunction in older patients with a history of alcohol abuse. Anesthesiology. 2007 Mar;106(3):423-30. doi: 10.1097/00000542-200703000-00005.
PubMed 17325499Youngblom E, DePalma G, Sands L, Leung J. The temporal relationship between early postoperative delirium and postoperative cognitive dysfunction in older patients: a prospective cohort study. Can J Anaesth. 2014 Dec;61(12):1084-92. doi: 10.1007/s12630-014-0242-6. Epub 2014 Oct 7.
PubMed 25287962Boos GL, Soares LF, Oliveira Filho GR. [Postoperative cognitive dysfunction: prevalence and associated factors.]. Rev Bras Anestesiol. 2005 Oct;55(5):517-24. doi: 10.1590/s0034-70942005000500006. Portuguese.
PubMed 19468642Burkhart CS, Steiner LA. Can postoperative cognitive dysfunction be avoided? Hosp Pract (1995). 2012 Feb;40(1):214-23. doi: 10.3810/hp.2012.02.962.
PubMed 22406897Damuleviciene G, Lesauskaite V, Macijauskiene J. [Postoperative cognitive dysfunction of older surgical patients]. Medicina (Kaunas). 2010;46(3):169-75. Lithuanian.
PubMed 20516755Blumberg FC, Fisch SM. Introduction: digital games as a context for cognitive development, learning, and developmental research. New Dir Child Adolesc Dev. 2013 Spring;2013(139):1-9. doi: 10.1002/cad.20026.
PubMed 23483688Green CS, Bavelier D. Learning, attentional control, and action video games. Curr Biol. 2012 Mar 20;22(6):R197-206. doi: 10.1016/j.cub.2012.02.012.
PubMed 22440805Fernandez-Aranda F, Jimenez-Murcia S, Santamaria JJ, Gunnard K, Soto A, Kalapanidas E, Bults RG, Davarakis C, Ganchev T, Granero R, Konstantas D, Kostoulas TP, Lam T, Lucas M, Masuet-Aumatell C, Moussa MH, Nielsen J, Penelo E. Video games as a complementary therapy tool in mental disorders: PlayMancer, a European multicentre study. J Ment Health. 2012 Aug;21(4):364-74. doi: 10.3109/09638237.2012.664302. Epub 2012 May 1.
PubMed 22548300Kuhn S, Lorenz R, Banaschewski T, Barker GJ, Buchel C, Conrod PJ, Flor H, Garavan H, Ittermann B, Loth E, Mann K, Nees F, Artiges E, Paus T, Rietschel M, Smolka MN, Strohle A, Walaszek B, Schumann G, Heinz A, Gallinat J; IMAGEN Consortium. Positive association of video game playing with left frontal cortical thickness in adolescents. PLoS One. 2014 Mar 14;9(3):e91506. doi: 10.1371/journal.pone.0091506. eCollection 2014.
PubMed 24633348Kuhn S, Gleich T, Lorenz RC, Lindenberger U, Gallinat J. Playing Super Mario induces structural brain plasticity: gray matter changes resulting from training with a commercial video game. Mol Psychiatry. 2014 Feb;19(2):265-71. doi: 10.1038/mp.2013.120. Epub 2013 Oct 29.
PubMed 24166407Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
PubMed 24005416Rosser JC Jr, Lynch PJ, Cuddihy L, Gentile DA, Klonsky J, Merrell R. The impact of video games on training surgeons in the 21st century. Arch Surg. 2007 Feb;142(2):181-6; discusssion 186. doi: 10.1001/archsurg.142.2.181.
PubMed 17309970Patel A, Schieble T, Davidson M, Tran MC, Schoenberg C, Delphin E, Bennett H. Distraction with a hand-held video game reduces pediatric preoperative anxiety. Paediatr Anaesth. 2006 Oct;16(10):1019-27. doi: 10.1111/j.1460-9592.2006.01914.x.
PubMed 16972829Russoniello CV, O'Brien K, Parks JM. EEG, HRV and Psychological Correlates while Playing Bejeweled II: A Randomized Controlled Study. Stud Health Technol Inform. 2009;144:189-92.
PubMed 19592761Saleem M, Anderson CA, Gentile DA. Effects of Prosocial, Neutral, and Violent Video Games on Children's Helpful and Hurtful Behaviors. Aggress Behav. 2012 Jul-Aug;38(4):281-7. doi: 10.1002/ab.21428.
PubMed 25363697
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02551952
- Acronym / sponsor ID
- MentalPlus® / Interventional Study Design
- Conditions
- Cognition Disorders, Impaired Cognition, Self-Assessment
- Keywords
- Games, Cognitive Tests, General Anesthesia, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Copenhagen, Harvard Medical School (HMS and HSDM), Max Planck Institute for Human Development
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study was conceived as a randomized, double-blind exploratory trial. It received the approval of the Ethics Committee for Research Project Analysis (CAPPesq) of the Clinical Board, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP).
| Arm | Type | Receives |
|---|---|---|
| MentalPlus® PILOT-I | Experimental | Device: MentalPlus®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. |
| MentalPlus® PILOT-II | Experimental | Device: MentalPlus®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®. |
| Group I: MentalPlus® | Active comparator | Device: 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). |
| Group II: MentalPlus® | Sham comparator | Device: 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MentalPlus®Also: Brazilian National Library Foundation nº 663707Validate 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. | Device | Group I: MentalPlus®, Group II: MentalPlus®, MentalPlus® PILOT-I, MentalPlus® PILOT-II |
Primary outcome
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.
1 secondary outcome
Change From Baseline in Neuropsychological Scores on the MentalPlus® Scale for memory, attention and executive function at 20 days.
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Results publication: PubMed 17325499Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Hyde TF, Reddy DM, Hudetz AG, Warltier DC. Postoperative cognitive dysfunction in older patients with a history of alcohol abuse. Anesthesiology. 2007 Mar;106(3):423-30. doi: 10.1097/00000542-200703000-00005.
- Results publication: PubMed 25287962Youngblom E, DePalma G, Sands L, Leung J. The temporal relationship between early postoperative delirium and postoperative cognitive dysfunction in older patients: a prospective cohort study. Can J Anaesth. 2014 Dec;61(12):1084-92. doi: 10.1007/s12630-014-0242-6. Epub 2014 Oct 7.
- Results publication: PubMed 19468642Boos GL, Soares LF, Oliveira Filho GR. [Postoperative cognitive dysfunction: prevalence and associated factors.]. Rev Bras Anestesiol. 2005 Oct;55(5):517-24. doi: 10.1590/s0034-70942005000500006. Portuguese.
- Results publication: PubMed 22406897Burkhart CS, Steiner LA. Can postoperative cognitive dysfunction be avoided? Hosp Pract (1995). 2012 Feb;40(1):214-23. doi: 10.3810/hp.2012.02.962.
- Results publication: PubMed 20516755Damuleviciene G, Lesauskaite V, Macijauskiene J. [Postoperative cognitive dysfunction of older surgical patients]. Medicina (Kaunas). 2010;46(3):169-75. Lithuanian.
- Results publication: PubMed 23483688Blumberg FC, Fisch SM. Introduction: digital games as a context for cognitive development, learning, and developmental research. New Dir Child Adolesc Dev. 2013 Spring;2013(139):1-9. doi: 10.1002/cad.20026.
- Results publication: PubMed 22440805Green CS, Bavelier D. Learning, attentional control, and action video games. Curr Biol. 2012 Mar 20;22(6):R197-206. doi: 10.1016/j.cub.2012.02.012.
- Results publication: PubMed 22548300Fernandez-Aranda F, Jimenez-Murcia S, Santamaria JJ, Gunnard K, Soto A, Kalapanidas E, Bults RG, Davarakis C, Ganchev T, Granero R, Konstantas D, Kostoulas TP, Lam T, Lucas M, Masuet-Aumatell C, Moussa MH, Nielsen J, Penelo E. Video games as a complementary therapy tool in mental disorders: PlayMancer, a European multicentre study. J Ment Health. 2012 Aug;21(4):364-74. doi: 10.3109/09638237.2012.664302. Epub 2012 May 1.
- Results publication: PubMed 24633348Kuhn S, Lorenz R, Banaschewski T, Barker GJ, Buchel C, Conrod PJ, Flor H, Garavan H, Ittermann B, Loth E, Mann K, Nees F, Artiges E, Paus T, Rietschel M, Smolka MN, Strohle A, Walaszek B, Schumann G, Heinz A, Gallinat J; IMAGEN Consortium. Positive association of video game playing with left frontal cortical thickness in adolescents. PLoS One. 2014 Mar 14;9(3):e91506. doi: 10.1371/journal.pone.0091506. eCollection 2014.
- Results publication: PubMed 24166407Kuhn S, Gleich T, Lorenz RC, Lindenberger U, Gallinat J. Playing Super Mario induces structural brain plasticity: gray matter changes resulting from training with a commercial video game. Mol Psychiatry. 2014 Feb;19(2):265-71. doi: 10.1038/mp.2013.120. Epub 2013 Oct 29.
- Results publication: PubMed 24005416Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
- Results publication: PubMed 17309970Rosser JC Jr, Lynch PJ, Cuddihy L, Gentile DA, Klonsky J, Merrell R. The impact of video games on training surgeons in the 21st century. Arch Surg. 2007 Feb;142(2):181-6; discusssion 186. doi: 10.1001/archsurg.142.2.181.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lívia SS Valentin, Ph.D. principal investigator
Faculty of Medicine of the University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MentalPlus® in people with Cognition Disorders and Impaired Cognition, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of cognitive functions: executive, memory and attention on the MentalPlus® Scale (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551952, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.