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

NCT06536348 | Not Yet Recruiting

• 2 other identifiers: 81274724.0.0000.515213585
• Study Type: observational
• Target: 958
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; motor assessment; non-motor assessment; database; computer vision; inertial sensors

Outcome Measures

Primary Outcomes (34)

• 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

• 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

• Visual Acuity

  Visual Acuity measured according to the Snellen test (https://www.ncbi.nlm.nih.gov/books/NBK558961/)

  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

• 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

Study Arms (2)

Experimental group

Group of subjects with Parkinson's disease

Control group

Neurological healthy subjects

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Uberlandia: lead
• Núcleo de Inovação e Avaliação Tecnológica em Saúde: collaborator
• Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia: collaborator
• Associação Parkinson Goiás: collaborator
• Centro Universitário Araguaia (UniAraguaia): collaborator
• Laboratório de Análise de Movimento e Processamento de Sinais: collaborator

Study Sites (5)

Laboratório de Análise de Movimento e Processamento de Sinais

Brasília, Federal District, 72220-275, Brazil

Location

Centro Universitário Araguaia (UniAraguaia)

Goiânia, Goiás, 74.223-060, Brazil

Location

Associação Parkinson Goiás

Goiânia, Goiás, 74265-320, Brazil

Location

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

Uberlândia, Minas Gerais, 38405-318, Brazil

Location

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

Uberlândia, Minas Gerais, 38408-100, Brazil

Location

Related Publications (23)

• 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 BACKGROUND

• World Health Organization, Parkinson disease, 2023.

  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.

  PMID: 16482566 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38391822 BACKGROUND

• 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.

  PMID: 37346638 BACKGROUND

• 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

  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

  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.

  PMID: 36292272 BACKGROUND

• 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.

  PMID: 36766984 BACKGROUND

• 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.

  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.

  PMID: 28038673 BACKGROUND

• 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.

  PMID: 28852889 BACKGROUND

• 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.

  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.

  PMID: 30532798 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 26224145 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Adriano Andrade, PhD

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriano Andrade, PhD

CONTACT

+55 34 3239-4761; adriano@ufu.br

Adriano Andrade, PhD

CONTACT

+ 34 3239-4761; adriano@ufu.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 2, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2034
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• 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.

Locations

BR (5)