The MentalPlus® for Assessment and Rehabilitation of Cognitive Function After Remission of the Symptoms of COVID-19

NCT04632719 | Completed DMC

• 1 other identifier: MentalPlus®
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.

Conditions

Cognitive Impairment; Covid19; Cognitive Dysfunction; Depression, Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Assessment of cognitive functions after COVID-19

  The evaluation of cognitive functions by the digital game MentalPlus® (a scale of assessment and cognitive rehabilitation) will take place as follows: Scores range from 0 \[Not improved\] to 10 \[fully improved\] at cognitive functions memory, attention and executive after training with Scale. This game is already validated and standardized for the global population. The test takes 25 minutes to play, is playful and self-explanatory. It has twelve themes with cognitive functions: short and long-term memory; selective, alternate and concentrated attention, inhibitory control of executive function and visual perception. MentalPlus® is completely randomized in its phases and themes. Therefore, the game can be used for cognitive assessment with a single theme (25 minutes of execution) or rehabilitation on 10 more themes and a final theme for reassessment of cognitive functions.

  1 year

Secondary Outcomes (1)

• Rehabilitation of cognitive functions after COVID-19

  1 year

Study Arms (2)

Covid-19 Study Group

EXPERIMENTAL

The Study Group will be the group that was remiss for COVID-19 and has some of the mentioned comorbidities as asthma, cardiovascular disease, cancer even if controlled by drugs or treatments.

Device: The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19

Covid-19 Control Group

ACTIVE COMPARATOR

The Control Group will be the group with remissive patients without the aforementioned comorbidities. We will assess whether comorbidities can worsen cognitive functions' impairment after the remission of the symptoms of COVID-19.

Device: The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19

Interventions

The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19 DEVICE

Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.

Covid-19 Control Group; Covid-19 Study Group

Eligibility Criteria

• Age: 8 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by COVID-19 with or without comorbidity for cardiovascular diseases, diabetes mellitus, hypertension, cancer, asthma between the ages of 8 and 88 years of both sexes and illiterate or literate.

You may not qualify if:

• Disability for the instrument's use: limitation for the mobility of the upper limbs, presence of significant mental retardation that compromises the understanding of the instructions for the use of MentalPlus®, significant lowering of visual acuity.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Livia Stocco Sanches Valentin

São Paulo, São Paulo, 02019-010, Brazil

Location

Livia Stocco Sanches Valentin

São Paulo, 02019010, Brazil

Location

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MeSH Terms

Conditions

Cognitive Dysfunction; COVID-19; Depression; Anxiety Disorders

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Livia S. Valentin, Ph.D

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

• Luiz Antonio M Cesar, Ph.D

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

• Luiz Aparecido Bortolotto, Ph.D

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study has two groups. The Study Group will be the group that was remissive for COVID-19 and has some of the mentioned comorbidities, even if controlled by drugs or treatments. The Control Group will be the group with remissive patients without the aforementioned comorbidities. We will assess whether comorbidities can worsen the impairment of cognitive functions after the remission of the symptoms of COVID-19. The purpose of the research is to verify; whether COVID-19 alone in moderate to severe cases causes cognitive impairment or whether predisposing factors for such comorbidities would cause further impairment in cognitive functions after COVID-19 contraction and remission.

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 17, 2020
• Study Start: November 8, 2020
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months
• Access Criteria: Access will be made available by MentalPlus® APP and email.

Locations

BR (2)