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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Estimated): 958

Contacts and Locations

• Study Contact: Name: Adriano Andrade, PhD; Phone Number: +55 34 3239-4761; Email: adriano@ufu.br
• Study Contact Backup: Name: Adriano Andrade, PhD; Phone Number: + 34 3239-4761; Email: adriano@ufu.br

Study Locations

• Brazil
  • Federal District
    • Brasília, Federal District, Brazil, 72220-275
      • Not yet recruiting
      • Laboratório de Análise de Movimento e Processamento de Sinais
      • Contact: Clarissa Cardoso dos Santos Couto Paz, PhD; Email: clarissacardoso@unb.br
  • Goiás
    • Goiânia, Goiás, Brazil, 74.223-060
      • Recruiting
      • Centro Universitário Araguaia (UniAraguaia)
      • Contact: Tatiana Carilly Oliveira Andrade, PhD; Email: tatiana@uniaraguaia.edu.br
    • Goiânia, Goiás, Brazil, 74265-320
      • Not yet recruiting
      • Associação Parkinson Goiás
      • Contact: Adriano Andrade, PhD; Email: adriano@ufu.br
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38405-318
      • Recruiting
      • Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia
      • Contact: Adriano Andrade, PhD; Email: adriano@ufu.br
    • Uberlândia, Minas Gerais, Brazil, 38408-100
      • Recruiting
      • Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in Health
      • Contact: Adriano Andrade, PhD; Email: adriano@ufu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Experimental group: Individuals diagnosed with Parkinson's disease
• Control group: Individuals not having Parkinson's disease (PD) or other neurological disease that resembles PD;

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental group; Group of subjects with Parkinson's disease
Control group; Neurological healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Sex: male, female	10 years
Age	Age in years	10 years
Length of schooling	Length of schooling in years	10 years
Weight	Weight in kg	10 years
Height	Height in cm	10 years
Blood type	Blood type: A+, A-, B+, B-, O+, O-, AB+, AB-	10 years
Economic Rating Score	Economic rating as given by the Brazilian Economic Classification Criteria (Brazilian Criteria) - https://www.abep.org/criterioBr/01_cceb_2022_eng.pdf	10 years
Primary ICD	Primary disorder classification according to the International Statistical Classification of Diseases and Related Health Problems (ICD) https://www.who.int/standards/classifications/classification-of-diseases	10 years
Secondary ICDs	Secondary disorder according to the International Statistical Classification of Diseases and Related Health Problems (ICD) https://www.who.int/standards/classifications/classification-of-diseases	10 years
Medications in use	name and daily dose of medications	10 years
Family history related to the primary ICD	Is there family history related to the primary ICD? (yes, no)	10 years
Date of symptom onset related to the primary ICD	date	10 years
Date of diagnosis related to the primary ICD	date	10 years
Current city of residence	City of residence in Brazil	10 years
Current state of residence	State of residence in Brazil	10 years
Civil status	married, single, divorced, and widowed	10 years
Housing classification	Housing classification by type of housing ownership rights: State-owned housing, Municipality-owned housing, Natural person's owned housing, Legal person's owned housing, Private renting, Other	10 years
Household size	The number of adults and children living in a home	10 years
Laterality	Laterality refers to the preference for using one side of the body over the other and is most commonly associated with hand dominance, such as being right-handed or left-handed, e.g., Right-handedness, Left-handedness, Ambidexterity, Mixed-handedness (Cross-dominance).	10 years
Use of technology	Verification if the participant has had contact with one of the following devices: mobile, personal computer, mouse, webcam, keyboard, microphone, earphone.	10 years
Occupation	Profession according to the Brazilian Classification of Occupation (https://www.mtecbo.gov.br/cbosite/pages/home.jsf)	10 years
Monthly wage	Monthly wage in Brazilian Reais	10 years
Head movement amplitude	Head movement amplitude in degrees	10 years
Head movement speed	Head movement speed in degrees per second	10 years
Facial expression	Facial expression evaluation according to the Facial Action Coding System (FACS)	10 years
Saccadic eye movement	Speed and regularity of eye movement (degrees per second and latency in ms)	10 years
Smooth pursuit eye movement	Smooth pursuit are quantified by the gain (how well the eyes follow the target in speed) and phase (distance to the target during pursuit)	10 years
Handwriting movement analysis	Handwriting speed (seconds) and quality	10 years
Visual Acuity	Visual Acuity measured according to the Snellen test (https://www.ncbi.nlm.nih.gov/books/NBK558961/)	10 years
Dysarthria	Dysarthria measured according to the protocol for the evaluation of central dysartries in patients with Parkinson's Disease (https://doi.org/10.1590/S1516-18462011005000030)	10 years
Hand movement	Hand movement in degrees per second	10 years
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Clinical scale for measuring signs and symptoms of Parkinson's disease (https://www.movementdisorders.org/MDS/MDS-Rating-Scales/MDS-Unified-Parkinsons-Disease-Rating-Scale-MDS-UPDRS.htm?gad_source=1&gclid=CjwKCAjwnqK1BhBvEiwAi7o0X6DuHrFh3qftNQ1N9AGWMkFo4BpG6b3hAFWnoh2Dwu86DPY53ZXpKRoCBRYQAvD_BwE) Each item of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale will be evaluated as 0: Normal; 1: Slight; 2: Mild; 3: Moderate; 4: Severe. The minimum value of the scale is 0, whereas the maximum value is 4. Higher scores mean a worse outcome.	10 years
Depression	Depression measured according to the Geriatric Depression Scale (GDS) https://geriatrictoolkit.missouri.edu/cog/GDS_SHORT_FORM.PDF The Geriatric Depression Scale has 15 items. The minimum total score is zero, and the maximum is 15. Higher scores mean a worse outcome.	10 years
Cognition	Cognition measured according to the Montreal Cognitive Assessment (MOCA) scale The Montreal Cognitive Assessment (MoCA) is a 30-point test. The minimum total score is zero, and the maximum is 30. Higher scores mean a better outcome.	10 years

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Collaborators: Núcleo de Inovação e Avaliação Tecnológica em Saúde; Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia; Associação Parkinson Goiás; Centro Universitário Araguaia (UniAraguaia); Laboratório de Análise de Movimento e Processamento de Sinais
• Investigators: Principal Investigator: Adriano Andrade, PhD, Federal University of Uberlândia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• World Health Organization, Parkinson disease, 2023.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• National Commission for the Incorporation of Technologies in the SUS - CONITEC, Clinical Protocol and Therapeutic Guidelines Parkinson's Disease, 2017.
• A. S. Fracassi, A. R. Gatto, S. Weber, A. A. Spadotto, P. W. Ribeiro and A. O. Schelp,
• 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.
• J. F. Cecato, J. M. Montiel, D. Bartholomeu and J. E. Martinelli,

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2034

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson's disease; inertial sensors; database; motor assessment; computer vision; non-motor assessment
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 81274724.0.0000.5152; 13585 (Other Identifier: Empresa Brasileira de Serviços Hospitalares (EBSERH))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be anonymised, stored in a safe and international plataform (Zenodo - https://github.com/NIATS-UFU). Only information that can be used to identify the subjects will be shared.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Researchers that wish to have access to the data can request access at https://github.com/NIATS-UFU. Full access will be granted for research purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No