Digital Game: A Scale to Evaluate the Perioperative Cognitive Function

NCT02551952 | Completed DMC

• 1 other identifier: Interventional Study Design
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition Disorders; Impaired Cognition; Self-Assessment

Keywords

Games; Cognitive Tests; General Anesthesia; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Neuropsychological Scores on the MentalPlus® Scale for memory, attention and executive function at 20 days.

  20 days

Study Arms (4)

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.

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®.

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).

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)

Device: MentalPlus®

Interventions

MentalPlus® DEVICE

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.

Also known as: Brazilian National Library Foundation nº 663707

Group I: MentalPlus®; Group II: MentalPlus®; MentalPlus® PILOT-I; MentalPlus® PILOT-II

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Livia Stocco Sanches Valentin

São Paulo, 02019010, Brazil

Location

Related Publications (45)

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MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Lívia SS Valentin, Ph.D.

  Faculty of Medicine of the University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization was performed using the website http://www.randomizer.org/form.htm, recorded on paper and stored in sealed opaque envelopes to be opened in the study room where volunteers would play the video game. The health professionals responsible for the game application were aware of the MentalPlus® game version arm just after openness of the envelopes. However, patients, neuropsychologists, and outcome assessors involved in the the study was kept blinded to the stratification group to which each patient belonged. The study groups were identified only after the evaluation of all patients and statistical analysis.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 16, 2015
• Study Start: July 8, 2021
• Primary Completion: July 4, 2022
• Study Completion: October 29, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)