Neuropsychological TestMentalPlus®NCT04637191
Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®
A study testing MentalPlus® in people with Neuropsychological Test, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropsychological Test
- What is being tested?
- MentalPlus®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jul 2020to 29 Nov 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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®.
- Conditions
- Neuropsychological Test
- Being tested
- MentalPlus®
- Keywords
- Digital games, Neuropsychology, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentalPlus®Device
Also called Digital Game
A digital game named MentalPlus will be used to evaluate the possibility of this game becoming a neuropsychological test.
| Study group | Role | What they receive |
|---|---|---|
| MentalPlus® | Experimental | 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. Receives: Device: MentalPlus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language.
Cognitive evaluation of 60 patients in the pre and postoperative period using the MentalPlus scale for the evaluation of postoperative cognitive dysfunction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start8 Jul 2020
- Primary completion29 Nov 2022
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Neuropsychological TestStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Livia Stocco Sanches Valentin, University of Sao Paulo
- Investigators
- Livia S Valentin, Ph.D, Principal investigator, University of Sao Paulo School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637191
- Sponsor's protocol ID
- USaoPaulo-I
- Acronym
- MentalPlus®
- Status last verified
- Mar 2024
- First submitted
- 30 May 2017
- 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 24166407Saleem 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 25363697Montag C, Weber B, Trautner P, Newport B, Markett S, Walter NT, Felten A, Reuter M. Does excessive play of violent first-person-shooter-video-games dampen brain activity in response to emotional stimuli? Biol Psychol. 2012 Jan;89(1):107-11. doi: 10.1016/j.biopsycho.2011.09.014. Epub 2011 Oct 5.
PubMed 21982747Gentile DA, Choo H, Liau A, Sim T, Li D, Fung D, Khoo A. Pathological video game use among youths: a two-year longitudinal study. Pediatrics. 2011 Feb;127(2):e319-29. doi: 10.1542/peds.2010-1353. Epub 2011 Jan 17.
PubMed 21242221Bavelier D, Green CS, Pouget A, Schrater P. Brain plasticity through the life span: learning to learn and action video games. Annu Rev Neurosci. 2012;35:391-416. doi: 10.1146/annurev-neuro-060909-152832.
PubMed 22715883Oei AC, Patterson MD. Enhancing cognition with video games: a multiple game training study. PLoS One. 2013;8(3):e58546. doi: 10.1371/journal.pone.0058546. Epub 2013 Mar 13.
PubMed 23516504
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
- Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®
- ClinicalTrials.gov ID
- NCT04637191
- Acronym / sponsor ID
- MentalPlus® / USaoPaulo-I
- Conditions
- Neuropsychological Test
- Keywords
- Digital games, Neuropsychology, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- 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
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 19 Nov 2020 (actual)
- 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.
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®.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MentalPlus® | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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: Digital GameA digital game named MentalPlus will be used to evaluate the possibility of this game becoming a neuropsychological test. | Device | MentalPlus® |
Primary outcome
Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language.
Time frame: 1 year
Cognitive evaluation of 60 patients in the pre and postoperative period using the MentalPlus scale for the evaluation of postoperative cognitive dysfunction.
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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 20516755Damuleviciene G, Lesauskaite V, Macijauskiene J. [Postoperative cognitive dysfunction of older surgical patients]. Medicina (Kaunas). 2010;46(3):169-75. Lithuanian.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 25363697Saleem 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.
- Background: PubMed 21982747Montag C, Weber B, Trautner P, Newport B, Markett S, Walter NT, Felten A, Reuter M. Does excessive play of violent first-person-shooter-video-games dampen brain activity in response to emotional stimuli? Biol Psychol. 2012 Jan;89(1):107-11. doi: 10.1016/j.biopsycho.2011.09.014. Epub 2011 Oct 5.
- 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.
Livia S Valentin, Ph.D principal investigator
University of Sao Paulo School of Medicine
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 Neuropsychological Test, 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 1 inclusion and 1 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. 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?
Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language. (time frame: 1 year). 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 NCT04637191, which also lists 24 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.