Menu
Recruiting NCT06536348

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

— Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Sex [Time frame: 10 years]
  • Age [Time frame: 10 years]
  • Length of schooling [Time frame: 10 years]
  • Weight [Time frame: 10 years]
  • Height [Time frame: 10 years]
  • Blood type [Time frame: 10 years]
  • Economic Rating Score [Time frame: 10 years]
  • Primary ICD [Time frame: 10 years]
  • Secondary ICDs [Time frame: 10 years]
  • Medications in use [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Brazil · 5 centers
  • Laboratório de Análise de Movimento e Processamento de Sinais — Brasília
  • Centro Universitário Araguaia (UniAraguaia) — Goiânia
  • Associação Parkinson Goiás — Goiânia
  • Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Ub — Uberlândia
  • Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology — Uberlândia

Publications

  • 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. PMID 28332488
  • World Health Organization, Parkinson disease, 2023.
  • 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. PMID 16482566
  • 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. PMID 29934195
  • 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. PMID 31733690
  • 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. PMID 11052215
  • 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. PMID 28150045
  • 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. PMID 15542009

Identifiers

NCT: NCT06536348 · 81274724.0.0000.5152 · 13585

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗