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Trial record 19 of 24 for:    13688369 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02551952
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Copenhagen
Harvard Medical School
Max Planck Institute for Human Development
Information provided by (Responsible Party):
Livia Stocco Sanches Valentin, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Cognition Disorders Impaired Cognition Self-Assessment Device: MentalPlus® Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : July 4, 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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 Name: 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 Name: 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 Name: 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 Name: Brazilian National Library Foundation nº 663707




Primary Outcome Measures :
  1. 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 standardized to the global population.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551952


Contacts
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Contact: Lívia SS Valentin, Ph.D. +5511999959215 lssv@usp.br
Contact: Julia SS Valentin, Bacharel +5511971958165 jssvtocco@gmail.com

Locations
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Brazil
Livia Stocco Sanches Valentin Recruiting
Sao Paulo, Brazil, 02019010
Contact: Livia SS Valentin, Ph.D    +5511999959215    lssv@usp.br   
Contact: Julia SS Valentin, Bacharel    +5511971958165    jssvtocco@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Copenhagen
Harvard Medical School
Max Planck Institute for Human Development
Investigators
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Principal Investigator: Lívia SS Valentin, Ph.D. Faculty of Medicine of the University of Sao Paulo

Publications of Results:
Valentin LSS, Valentin TSS, Carmona MJC, Aguilar G, Pires VY, Garcia RC, et al. Digital Game Test Neuropsychology. Fundação Biblioteca Nacional. 2014.
Valentin LSS, Valentin TSS, Carmona MJC, Garcia RC, Correa RD, Gondim GB, et al. Mental Plus. INPI - Instituto Nacional da Propriedade Intelectual. 2014.
Beck AT SR. Beck depression Inventory. manual. San Antonio: Psychology Corporation. 1993.

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Responsible Party: Livia Stocco Sanches Valentin, Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02551952     History of Changes
Other Study ID Numbers: Interventional Study Design
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Livia Stocco Sanches Valentin, University of Sao Paulo:
Games
Cognitive Tests
General Anesthesia
Surgery
Additional relevant MeSH terms:
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Cognition Disorders
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders