PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil

NCT ID: NCT06536348

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

958 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2034-10-01

Brief Summary

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This is an observational, cross-sectional study with a control group, with the general objective of developing and evaluating a national database, unprecedented in Brazil, containing clinical, epidemiological, motor, and non-motor aspects of Parkinson's disease (PD). The database will be open and accessible to national and international researchers in order to contribute to the advancement of research related to PD. The aim is to collect data, in a paired way, from a control group and an experimental group. Data collection will include the application of questionnaires, the execution of motor activities, and clinical scales. Information that can identify the participants will be removed from the database for later storage in a repository. Quantitative, qualitative, and descriptive variables from the database will be estimated in order to characterise and contrast the groups studied. The results of this study will contribute to a better characterization of the staging of PD as a function of the epidemiological, motor, and non-motor aspects evaluated, as well as to the development of technologies and methods that can be applied in clinical practice.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Experimental group

Group of subjects with Parkinson's disease

No interventions assigned to this group

Control group

Neurological healthy subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Experimental group: (i) present a neurological diagnosis of Parkinson's disease; (ii) be classified between stages I to IV of the Hoehn \& Yahr Scale; (iii) have central visual acuity equal to or greater than 20/40 (equivalent to 0.50) in each eye or equal to or greater than 20/30 (equivalent to 0.66) in one eye according to the Snellen scale.
* Control group: (i) not having a neurological diagnosis of Parkinson's disease or other neurological disease that resembles PD; (ii) have central visual acuity equal to or greater than 20/40 (equivalent to 0.50) in each eye or equal to or greater than 20/30 (equivalent to 0.66) in one eye according to the Snellen scale.

Exclusion Criteria

For both groups, individuals who have other neurological or musculoskeletal diseases that interfere with the execution of the tests will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Núcleo de Inovação e Avaliação Tecnológica em Saúde

UNKNOWN

Sponsor Role collaborator

Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia

UNKNOWN

Sponsor Role collaborator

Associação Parkinson Goiás

UNKNOWN

Sponsor Role collaborator

Centro Universitário Araguaia (UniAraguaia)

UNKNOWN

Sponsor Role collaborator

Laboratório de Análise de Movimento e Processamento de Sinais

UNKNOWN

Sponsor Role collaborator

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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Adriano de Oliveira Andrade

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriano Andrade, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Laboratório de Análise de Movimento e Processamento de Sinais

Brasília, Federal District, Brazil

Site Status

Centro Universitário Araguaia (UniAraguaia)

Goiânia, Goiás, Brazil

Site Status

Associação Parkinson Goiás

Goiânia, Goiás, Brazil

Site Status

Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia

Uberlândia, Minas Gerais, Brazil

Site Status

Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in Health

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Adriano Andrade, PhD

Role: CONTACT

+55 34 3239-4761

Adriano Andrade, PhD

Role: CONTACT

+ 34 3239-4761

Facility Contacts

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Clarissa Cardoso dos Santos Couto Paz, PhD

Role: primary

Adriano Andrade, PhD

Role: primary

Adriano Andrade, PhD

Role: primary

Adriano Andrade, PhD

Role: primary

References

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Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE. Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013. doi: 10.1038/nrdp.2017.13.

Reference Type BACKGROUND
PMID: 28332488 (View on PubMed)

World Health Organization, Parkinson disease, 2023.

Reference Type BACKGROUND

Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806.

Reference Type BACKGROUND
PMID: 16482566 (View on PubMed)

Vale TC, Barbosa MT, Resende EPF, Maia DP, Cunningham MCQ, Guimaraes HC, Machado JCB, Teixeira AL, Cardoso F, Caramelli P. Parkinsonism in a population-based study of individuals aged 75+ years: The Pieta study. Parkinsonism Relat Disord. 2018 Nov;56:76-81. doi: 10.1016/j.parkreldis.2018.06.030. Epub 2018 Jun 19.

Reference Type BACKGROUND
PMID: 29934195 (View on PubMed)

Simon DK, Tanner CM, Brundin P. Parkinson Disease Epidemiology, Pathology, Genetics, and Pathophysiology. Clin Geriatr Med. 2020 Feb;36(1):1-12. doi: 10.1016/j.cger.2019.08.002. Epub 2019 Aug 24.

Reference Type BACKGROUND
PMID: 31733690 (View on PubMed)

Obeso JA, Rodriguez-Oroz MC, Rodriguez M, Lanciego JL, Artieda J, Gonzalo N, Olanow CW. Pathophysiology of the basal ganglia in Parkinson's disease. Trends Neurosci. 2000 Oct;23(10 Suppl):S8-19. doi: 10.1016/s1471-1931(00)00028-8.

Reference Type BACKGROUND
PMID: 11052215 (View on PubMed)

Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1.

Reference Type BACKGROUND
PMID: 28150045 (View on PubMed)

Dickson JM, Grunewald RA. Somatic symptom progression in idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2004 Dec;10(8):487-92. doi: 10.1016/j.parkreldis.2004.05.005.

Reference Type BACKGROUND
PMID: 15542009 (View on PubMed)

Cabral AM, Lora-Millan JS, Pereira AA, Rocon E, Andrade AO. On the Effect of Vibrotactile Stimulation in Essential Tremor. Healthcare (Basel). 2024 Feb 9;12(4):448. doi: 10.3390/healthcare12040448.

Reference Type BACKGROUND
PMID: 38391822 (View on PubMed)

Cardoso Mendes L, Abreu Rosa de Sa A, Alves Marques I, Morere Y, de Oliveira Andrade A. RehaBEElitation: the architecture and organization of a serious game to evaluate motor signs in Parkinson's disease. PeerJ Comput Sci. 2023 Mar 15;9:e1267. doi: 10.7717/peerj-cs.1267. eCollection 2023.

Reference Type BACKGROUND
PMID: 37346638 (View on PubMed)

S. Costa, I. A. Marques, A. Bevilaqua, A. Rabelo, L. Luiz, A. Cabral, N. Faustino, M. Okereke, M. Fraga Vieira e A. de Oliveira Andrade, "Biomechanical Evaluation of an Exoskeleton for Rehabilitation of Individuals with Parkinson's Disease," IRBM, vol. 44, p. 100741, February 2023

Reference Type BACKGROUND

L. C. Mendes, A. M. Cabral, C. M. Alves, Y. Morère e A. de Oliveira Andrade, "Objective assessment of tremor in Parkinson's disease using the RehaBEElitation serious game," em 2023 IEEE International Conference on Metrology for eXtended Reality, Artificial Intelligence and Neural Engineering (MetroXRAINE), 2023

Reference Type BACKGROUND

Mendes LC, Marques IA, Alves CM, Vieira MF, Junior EAL, Pereira AA, Naves ELM, Oliveira FHM, Bourhis G, Pino P, Morere Y, Andrade AO. Multidimensional Assessment of Individuals with Parkinson's Disease: Development and Structure Validation of a Self-Assessment Questionnaire. Healthcare (Basel). 2022 Sep 21;10(10):1823. doi: 10.3390/healthcare10101823.

Reference Type BACKGROUND
PMID: 36292272 (View on PubMed)

Nobrega LR, Rocon E, Pereira AA, Andrade AO. A Novel Physical Mobility Task to Assess Freezers in Parkinson's Disease. Healthcare (Basel). 2023 Jan 31;11(3):409. doi: 10.3390/healthcare11030409.

Reference Type BACKGROUND
PMID: 36766984 (View on PubMed)

L. C. Mendes, A. Moura Cabral, C. M. Alves, Y. Morere, I. A. Marques e A. de Oliveira Andrade, "Objective Evaluation of Bradykinesia Using the RehaBEElitation Serious Game," em 2022 IEEE Workshop on Complexity in Engineering (COMPENG), 2022.

Reference Type BACKGROUND

Machado AR, Zaidan HC, Paixao AP, Cavalheiro GL, Oliveira FH, Junior JA, Naves K, Pereira AA, Pereira JM, Pouratian N, Zhuo X, O'Keeffe A, Sharim J, Bordelon Y, Yang L, Vieira MF, Andrade AO. Feature visualization and classification for the discrimination between individuals with Parkinson's disease under levodopa and DBS treatments. Biomed Eng Online. 2016 Dec 30;15(1):169. doi: 10.1186/s12938-016-0290-y.

Reference Type BACKGROUND
PMID: 28038673 (View on PubMed)

Rabelo AG, Neves LP, Paixao APS, Oliveira FHM, de Souza LAPS, Vieira MF, Pereira AA, Andrade AO. Objective Assessment of Bradykinesia Estimated from the Wrist Extension in Older Adults and Patients with Parkinson's Disease. Ann Biomed Eng. 2017 Nov;45(11):2614-2625. doi: 10.1007/s10439-017-1908-3. Epub 2017 Aug 29.

Reference Type BACKGROUND
PMID: 28852889 (View on PubMed)

L. C. V. Ferreira, A. G. Rabelo, M. F. Vieira, A. A. Pereira e A. d. O. Andrade, "Gait variability and symmetry assessment with inertial sensors for quantitative discrimination of Trendelenburg sign in total hip arthroplasty patients: a pilot study based on convenience sampling," Research on Biomedical Engineering, vol. 34, p. 65-72, March 2018.

Reference Type BACKGROUND

Oliveira FHM, Machado ARP, Andrade AO. On the Use of t-Distributed Stochastic Neighbor Embedding for Data Visualization and Classification of Individuals with Parkinson's Disease. Comput Math Methods Med. 2018 Nov 4;2018:8019232. doi: 10.1155/2018/8019232. eCollection 2018.

Reference Type BACKGROUND
PMID: 30532798 (View on PubMed)

National Commission for the Incorporation of Technologies in the SUS - CONITEC, Clinical Protocol and Therapeutic Guidelines Parkinson's Disease, 2017.

Reference Type BACKGROUND

A. S. Fracassi, A. R. Gatto, S. Weber, A. A. Spadotto, P. W. Ribeiro and A. O. Schelp,

Reference Type BACKGROUND

Woo EH, White P, Lai CW. Ergonomics standards and guidelines for computer workstation design and the impact on users' health - a review. Ergonomics. 2016 Mar;59(3):464-75. doi: 10.1080/00140139.2015.1076528. Epub 2015 Sep 24.

Reference Type BACKGROUND
PMID: 26224145 (View on PubMed)

J. F. Cecato, J. M. Montiel, D. Bartholomeu and J. E. Martinelli,

Reference Type BACKGROUND

Other Identifiers

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13585

Identifier Type: OTHER

Identifier Source: secondary_id

81274724.0.0000.5152

Identifier Type: -

Identifier Source: org_study_id

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