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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04632719
Other study ID # MentalPlus®
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2020
Est. completion date December 29, 2023

Study information

Verified date March 2024
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 29, 2023
Est. primary completion date December 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 88 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Brazil Livia Stocco Sanches Valentin Sao Paulo
Brazil Livia Stocco Sanches Valentin São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (40)

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.

Asadi-Pooya AA, Simani L. Central nervous system manifestations of COVID-19: A systematic review. J Neurol Sci. 2020 Jun 15;413:116832. doi: 10.1016/j.jns.2020.116832. Epub 2020 Apr 11. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Blumberg FC, Fisch SM. Introduction: digital games as a context for cognitive development, learning, and developmental research. New Dir Child Adolesc Dev. 2013 Spring;2013(139):1-9. doi: 10.1002/cad.20026. — View Citation

Boot WR, Blakely DP, Simons DJ. Do action video games improve perception and cognition? Front Psychol. 2011 Sep 13;2:226. doi: 10.3389/fpsyg.2011.00226. eCollection 2011. — View Citation

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. — View Citation

Castellino SM, Ullrich NJ, Whelen MJ, Lange BJ. Developing interventions for cancer-related cognitive dysfunction in childhood cancer survivors. J Natl Cancer Inst. 2014 Jul 30;106(8):dju186. doi: 10.1093/jnci/dju186. Print 2014 Aug. — View Citation

Chigr F, Merzouki M, Najimi M. Comment on "The neuroinvasive potential of SARS-CoV-2 may play a role in the respiratory failure of COVID-19 patients". J Med Virol. 2020 Jul;92(7):703-704. doi: 10.1002/jmv.25960. Epub 2020 May 22. — View Citation

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. — View Citation

Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10. — View Citation

Cortegiani A, Ippolito M, Ingoglia G, Iozzo P, Giarratano A, Einav S. Update I. A systematic review on the efficacy and safety of chloroquine/hydroxychloroquine for COVID-19. J Crit Care. 2020 Oct;59:176-190. doi: 10.1016/j.jcrc.2020.06.019. Epub 2020 Jul 11. — View Citation

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. — View Citation

Edelmann F, Stahrenberg R, Gelbrich G, Durstewitz K, Angermann CE, Dungen HD, Scheffold T, Zugck C, Maisch B, Regitz-Zagrosek V, Hasenfuss G, Pieske BM, Wachter R. Contribution of comorbidities to functional impairment is higher in heart failure with preserved than with reduced ejection fraction. Clin Res Cardiol. 2011 Sep;100(9):755-64. doi: 10.1007/s00392-011-0305-4. Epub 2011 Mar 17. — View Citation

Fernandez-Aranda F, Jimenez-Murcia S, Santamaria JJ, Gunnard K, Soto A, Kalapanidas E, Bults RG, Davarakis C, Ganchev T, Granero R, Konstantas D, Kostoulas TP, Lam T, Lucas M, Masuet-Aumatell C, Moussa MH, Nielsen J, Penelo E. Video games as a complementary therapy tool in mental disorders: PlayMancer, a European multicentre study. J Ment Health. 2012 Aug;21(4):364-74. doi: 10.3109/09638237.2012.664302. Epub 2012 May 1. — View Citation

Fissler P, Kolassa IT, Schrader C. Educational games for brain health: revealing their unexplored potential through a neurocognitive approach. Front Psychol. 2015 Jul 24;6:1056. doi: 10.3389/fpsyg.2015.01056. eCollection 2015. — View Citation

Gottesman RF, Hillis AE. Predictors and assessment of cognitive dysfunction resulting from ischaemic stroke. Lancet Neurol. 2010 Sep;9(9):895-905. doi: 10.1016/S1474-4422(10)70164-2. — View Citation

Green CS, Bavelier D. Learning, attentional control, and action video games. Curr Biol. 2012 Mar 20;22(6):R197-206. doi: 10.1016/j.cub.2012.02.012. — View Citation

Kalaria RN, Akinyemi R, Ihara M. Stroke injury, cognitive impairment and vascular dementia. Biochim Biophys Acta. 2016 May;1862(5):915-25. doi: 10.1016/j.bbadis.2016.01.015. Epub 2016 Jan 22. — View Citation

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. — View Citation

Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17. — View Citation

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. — View Citation

Li YC, Bai WZ, Hashikawa T. Response to Commentary on "The neuroinvasive potential of SARS-CoV-2 may play a role in the respiratory failure of COVID-19 patients". J Med Virol. 2020 Jul;92(7):707-709. doi: 10.1002/jmv.25824. Epub 2020 Apr 10. — View Citation

Li YC, Bai WZ, Hashikawa T. The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients. J Med Virol. 2020 Jun;92(6):552-555. doi: 10.1002/jmv.25728. Epub 2020 Mar 11. — View Citation

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. — View Citation

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. — View Citation

Oei AC, Patterson MD. Enhancing cognition with video games: a multiple game training study. PLoS One. 2013;8(3):e58546. doi: 10.1371/journal.pone.0058546. Epub 2013 Mar 13. — View Citation

Pereira VFA, Valentin LSS. The MentalPlus(R) Digital Game Might Be an Accessible Open Source Tool to Evaluate Cognitive Dysfunction in Heart Failure with Preserved Ejection Fraction in Hypertensive Patients: A Pilot Exploratory Study. Int J Hypertens. 2018 Aug 6;2018:6028534. doi: 10.1155/2018/6028534. eCollection 2018. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sun P, Lu X, Xu C, Sun W, Pan B. Understanding of COVID-19 based on current evidence. J Med Virol. 2020 Jun;92(6):548-551. doi: 10.1002/jmv.25722. Epub 2020 Mar 5. — View Citation

Valentin LS, Pietrobon R, Aguiar Junior Wd, Rios RP, Stahlberg MG, Menezes IV, Osternack-Pinto K, Carmona MJ. Definition and application of neuropsychological test battery to evaluate postoperative cognitive dysfunction. Einstein (Sao Paulo). 2015 Jan-Mar;13(1):20-6. doi: 10.1590/S1679-45082015AO3152. — View Citation

Wu P, Hao X, Lau EHY, Wong JY, Leung KSM, Wu JT, Cowling BJ, Leung GM. Real-time tentative assessment of the epidemiological characteristics of novel coronavirus infections in Wuhan, China, as at 22 January 2020. Euro Surveill. 2020 Jan;25(3):2000044. doi: 10.2807/1560-7917.ES.2020.25.3.2000044. — View Citation

* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 1 year
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