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

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04632719
Collaborator
(none)
200
Enrollment
2
Locations
2
Arms
37.7
Anticipated Duration (Months)
100
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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

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

Study Type:
Interventional
Anticipated 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.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 :
Nov 8, 2020
Anticipated Primary Completion Date :
Dec 29, 2020
Anticipated Study Completion Date :
Dec 29, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Assessment of cognitive functions after COVID-19 [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 [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

Criteria

Ages Eligible for Study:
8 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Livia Stocco Sanches Valentin São Paulo SP Brazil 02019-010
2 Livia Stocco Sanches Valentin Sao Paulo Brazil 02019010

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Livia Stocco Sanches Valentin, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT04632719
Other Study ID Numbers:
  • MentalPlus®
First Posted:
Nov 17, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Cognitive Dysfunction

Study Results

No Results Posted as of Nov 17, 2020