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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04632719
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Livia Stocco Sanches Valentin, University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Covid19 Cognitive Dysfunction Depression, Anxiety Quality of Life Device: The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19 Not Applicable

Detailed Description:
Subjects who contracted COVID-19 and present remission of symptoms will be studied, with different age groups, illiterate or literate, of both genders and with different socio-demographic characteristics. The volunteers will be submitted to the application of MentalPlus® to assess cognitive functions and SF-8® to assess Quality of Life.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MentalPlus® for Assessment and Rehabilitation of Cognitive Functions After Remission of Symptoms of COVID-19
Actual Study Start Date : November 8, 2020
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Covid-19 Study Group
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
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.
Active Comparator: Covid-19 Control Group
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
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of cognitive functions after COVID-19 [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Rehabilitation of cognitive functions after COVID-19 [ Time Frame: 1 year ]
    Rehabilitation of cognitive functions: executive, attention, memory, visual perception, language, after the remission of the symptoms of COVID-19. MentalPlus® will be used in order to rehabilitate the cognitive functions of patients who have dysfunctions after COVID-19. The patient will play on alternate days (every other day) a theme of the game and will be rehabilitated through its 10 themes. At the end of these 10 themes, the patient will be reassessed by the last theme of the game, comprising a total of 12 themes. Each theme lasts for 25 minutes each.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 88 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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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): NCT04632719


Contacts
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Contact: Livia S. Valentin, Ph.D. +5511999959215 lssv@usp.br; livia.valentin@hc.fm.usp.br; dra.liviavalentin@gmail.com.br
Contact: Julia S. Valentin, Fellow +5511971958165 jssvtocco@gmail.com

Locations
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Brazil
Livia Stocco Sanches Valentin Recruiting
São Paulo, SP, Brazil, 02019-010
Contact: Livia Stocco S Valentin, Ph.D    +5511999959215    lssv@usp.br   
Contact: Julia S Valentin, Fellow    +5511971958165    jssvtocco@gmail.com   
Sub-Investigator: Luiz Antonio M Cesar, Ph.D         
Sub-Investigator: Luiz Aparecido Bortolotto, Ph.D         
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   
Sub-Investigator: Luiz Antonio M Cesar, Ph.D         
Sub-Investigator: Luiz Aparecido Bortolotto, Ph.D         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: 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
More Information
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Publications:
26. Valentin LSS, Valentin TSS, Carmona MJC, Aguilar G, Pires VY, Garcia RC, et al. Digital Game Test Neuropsychology. Fundação Biblioteca Nacional. 2014.
27. Valentin LSS, Valentin TSS, Carmona MJC, Garcia RC, Correa RD, Gondim GB, et al. Mental Plus. INPI - Instituto Nacional da Propriedade Intelectual. 2014.
28. KIRKWOOD, B. R. and STERNE, J. A. C (2006). Essential medical statistics. 2nd ed. Blackwell Science: Massachusetts, USA. p.502.
29. McCULLAGH, P. and NELDER, J. A., (1989). Generalized linear models. 2nd ed. Chapman and Hall: New York, USA. p.511.

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Responsible Party: Livia Stocco Sanches Valentin, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04632719    
Other Study ID Numbers: MentalPlus®
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study will be shared with researchers from international centers. Therefore, the information will be made available between centers so that everyone can follow the same research protocol.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months
Access Criteria: Access will be made available by MentalPlus® APP and email.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Cognitive Dysfunction
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders