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Cognitive ImpairmentMP-COVIDNCT04632719

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

A study testing The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19 in people with Cognitive Impairment and Covid19, run by University of Sao Paulo at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 88 yearsHealthy volunteers can take part
What is being tested?
The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesBrazil
Study dates
8 Nov 2020to 29 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 88 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Livia Stocco Sanches Valentin

    São Paulo, São Paulo, 02019-010

  • Livia Stocco Sanches Valentin

    São Paulo, 02019010

Other trials in Brazil

About this study

Official title: MentalPlus® for Assessment and Rehabilitation of Cognitive Functions After Remission of Symptoms of COVID-19

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.

Read the 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.

Being tested
The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Medical subject headings
Cognitive Dysfunction, COVID-19, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT04632719
Study groupRoleWhat they receive
Covid-19 Study GroupExperimentalThe 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.
Receives: 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 GroupActive comparatorThe 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.
Receives: Device: The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

  1. Rehabilitation of cognitive functions after COVID-19

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start8 Nov 2020
  3. Primary completion29 Dec 2020
  4. Study completion29 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04632719
Sponsor's protocol ID
MentalPlus®
Acronym
MP-COVID
Status last verified
Mar 2024
First submitted
14 Nov 2020
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.

    PubMed 32445440

  • Beigel JH, Tomashek KM, Dodd LE. Remdesivir for the Treatment of Covid-19 - Preliminary Report. Reply. N Engl J Med. 2020 Sep 3;383(10):994. doi: 10.1056/NEJMc2022236. Epub 2020 Jul 10. No abstract available.

    PubMed 32649078

  • Collins FS, Stoffels P. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): An Unprecedented Partnership for Unprecedented Times. JAMA. 2020 Jun 23;323(24):2455-2457. doi: 10.1001/jama.2020.8920. No abstract available.

    PubMed 32421150

  • Benussi A, Pilotto A, Premi E, Libri I, Giunta M, Agosti C, Alberici A, Baldelli E, Benini M, Bonacina S, Brambilla L, Caratozzolo S, Cortinovis M, Costa A, Cotti Piccinelli S, Cottini E, Cristillo V, Delrio I, Filosto M, Gamba M, Gazzina S, Gilberti N, Gipponi S, Imarisio A, Invernizzi P, Leggio U, Leonardi M, Liberini P, Locatelli M, Masciocchi S, Poli L, Rao R, Risi B, Rozzini L, Scalvini A, Schiano di Cola F, Spezi R, Vergani V, Volonghi I, Zoppi N, Borroni B, Magoni M, Pezzini A, Padovani A. Clinical characteristics and outcomes of inpatients with neurologic disease and COVID-19 in Brescia, Lombardy, Italy. Neurology. 2020 Aug 18;95(7):e910-e920. doi: 10.1212/WNL.0000000000009848. Epub 2020 May 22.

    PubMed 32444493

  • Pilotto A, Benussi A, Libri I, Masciocchi S, Poli L, Premi E, Alberici A, Baldelli E, Bonacina S, Brambilla L, Benini M, Caratozzolo S, Cortinovis M, Costa A, Cotti Piccinelli S, Cottini E, Cristillo V, Delrio I, Filosto M, Gamba M, Gazzina S, Gilberti N, Gipponi S, Giunta M, Imarisio A, Liberini P, Locatelli M, Schiano F, Rao R, Risi B, Rozzini L, Scalvini A, Vergani V, Volonghi I, Zoppi N, Borroni B, Magoni M, Leonardi M, Zanusso G, Ferrari S, Mariotto S, Pezzini A, Gasparotti R, Paolillo C, Padovani A. COVID-19 impact on consecutive neurological patients admitted to the emergency department. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):218-220. doi: 10.1136/jnnp-2020-323929. Epub 2020 Oct 14. No abstract available.

    PubMed 33055146

  • Laurendon T, Radulesco T, Mugnier J, Gerault M, Chagnaud C, El Ahmadi AA, Varoquaux A. Bilateral transient olfactory bulb edema during COVID-19-related anosmia. Neurology. 2020 Aug 4;95(5):224-225. doi: 10.1212/WNL.0000000000009850. Epub 2020 May 22. No abstract available.

    PubMed 32444492

  • Brun G, Hak JF, Coze S, Kaphan E, Carvelli J, Girard N, Stellmann JP. COVID-19-White matter and globus pallidum lesions: Demyelination or small-vessel vasculitis? Neurol Neuroimmunol Neuroinflamm. 2020 May 22;7(4):e777. doi: 10.1212/NXI.0000000000000777. Print 2020 Jul. No abstract available.

    PubMed 32444427

  • Rabano-Suarez P, Bermejo-Guerrero L, Mendez-Guerrero A, Parra-Serrano J, Toledo-Alfocea D, Sanchez-Tejerina D, Santos-Fernandez T, Folgueira-Lopez MD, Gutierrez-Gutierrez J, Ayuso-Garcia B, Gonzalez de la Aleja J, Benito-Leon J. Generalized myoclonus in COVID-19. Neurology. 2020 Aug 11;95(6):e767-e772. doi: 10.1212/WNL.0000000000009829. Epub 2020 May 21.

    PubMed 32439821

  • Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194.

    PubMed 29621031

  • Samieri C, Perier MC, Gaye B, Proust-Lima C, Helmer C, Dartigues JF, Berr C, Tzourio C, Empana JP. Association of Cardiovascular Health Level in Older Age With Cognitive Decline and Incident Dementia. JAMA. 2018 Aug 21;320(7):657-664. doi: 10.1001/jama.2018.11499.

    PubMed 30140876

  • Murray SG, Yazdany J, Kaiser R, Criswell LA, Trupin L, Yelin EH, Katz PP, Julian LJ. Cardiovascular disease and cognitive dysfunction in systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2012 Sep;64(9):1328-33. doi: 10.1002/acr.21691.

    PubMed 22549897

  • Motter JN, Devanand DP, Doraiswamy PM, Sneed JR. Clinical Trials to Gain FDA Approval for Computerized Cognitive Training: What Is the Ideal Control Condition? Front Aging Neurosci. 2016 Nov 2;8:249. doi: 10.3389/fnagi.2016.00249. eCollection 2016. No abstract available.

    PubMed 27853432

  • Biessels GJ, Despa F. Cognitive decline and dementia in diabetes mellitus: mechanisms and clinical implications. Nat Rev Endocrinol. 2018 Oct;14(10):591-604. doi: 10.1038/s41574-018-0048-7.

    PubMed 30022099

  • Kim HG. Cognitive dysfunctions in individuals with diabetes mellitus. Yeungnam Univ J Med. 2019 Sep;36(3):183-191. doi: 10.12701/yujm.2019.00255. Epub 2019 Jul 24.

    PubMed 31620632

  • Duarte-Garcia A, Romero-Diaz J, Juarez S, Cicero-Casarrubias A, Fragoso-Loyo H, Nunez-Alvarez C, Llorente L, Sanchez-Guerrero J. Disease activity, autoantibodies, and inflammatory molecules in serum and cerebrospinal fluid of patients with Systemic Lupus Erythematosus and Cognitive Dysfunction. PLoS One. 2018 May 3;13(5):e0196487. doi: 10.1371/journal.pone.0196487. eCollection 2018.

    PubMed 29723220

Questions about this trial

What is this clinical trial studying?

A study testing The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19 in people with Cognitive Impairment and Covid19, run by University of Sao Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of cognitive functions after COVID-19 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04632719, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

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