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NCT Number: NCT06536348

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.

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Key information

Conditions

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

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratório de Análise de Movimento e Processamento de Sinais, Brasília, Federal District, Brazil

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sex

    Time frame: 10 years

    Sex: male, female

  2. Age

    Time frame: 10 years

    Age in years

  3. Length of schooling

    Time frame: 10 years

    Length of schooling in years

  4. Weight

    Time frame: 10 years

    Weight in kg

  5. Height

    Time frame: 10 years

    Height in cm

  6. Blood type

    Time frame: 10 years

    Blood type: A+, A-, B+, B-, O+, O-, AB+, AB-

  7. Economic Rating Score

    Time frame: 10 years

    Economic rating as given by the Brazilian Economic Classification Criteria (Brazilian Criteria) - https://www.abep.org/criterioBr/01_cceb_2022_eng.pdf

  8. Primary ICD

    Time frame: 10 years

    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

  9. Secondary ICDs

    Time frame: 10 years

    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. Medications in use

    Time frame: 10 years

    name and daily dose of medications

  11. Family history related to the primary ICD

    Time frame: 10 years

    Is there family history related to the primary ICD? (yes, no)

  12. Date of symptom onset related to the primary ICD

    Time frame: 10 years

    date

  13. Date of diagnosis related to the primary ICD

    Time frame: 10 years

    date

  14. Current city of residence

    Time frame: 10 years

    City of residence in Brazil

  15. Current state of residence

    Time frame: 10 years

    State of residence in Brazil

  16. Civil status

    Time frame: 10 years

    married, single, divorced, and widowed

  17. Housing classification

    Time frame: 10 years

    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

  18. Household size

    Time frame: 10 years

    The number of adults and children living in a home

  19. Laterality

    Time frame: 10 years

    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).

  20. Use of technology

    Time frame: 10 years

    Verification if the participant has had contact with one of the following devices: mobile, personal computer, mouse, webcam, keyboard, microphone, earphone.

  21. Occupation

    Time frame: 10 years

    Profession according to the Brazilian Classification of Occupation (https://www.mtecbo.gov.br/cbosite/pages/home.jsf)

  22. Monthly wage

    Time frame: 10 years

    Monthly wage in Brazilian Reais

  23. Head movement amplitude

    Time frame: 10 years

    Head movement amplitude in degrees

  24. Head movement speed

    Time frame: 10 years

    Head movement speed in degrees per second

  25. Facial expression

    Time frame: 10 years

    Facial expression evaluation according to the Facial Action Coding System (FACS)

  26. Saccadic eye movement

    Time frame: 10 years

    Speed and regularity of eye movement (degrees per second and latency in ms)

  27. Smooth pursuit eye movement

    Time frame: 10 years

    Smooth pursuit are quantified by the gain (how well the eyes follow the target in speed) and phase (distance to the target during pursuit)

  28. Handwriting movement analysis

    Time frame: 10 years

    Handwriting speed (seconds) and quality

  29. MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Time frame: 10 years

    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.

  30. Depression

    Time frame: 10 years

    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.

  31. Visual Acuity

    Time frame: 10 years

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

  32. Cognition

    Time frame: 10 years

    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.

  33. Dysarthria

    Time frame: 10 years

    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)

  34. Hand movement

    Time frame: 10 years

    Hand movement in degrees per second

Study contacts

Contact information is provided by the study sponsor or research team.

Adriano Andrade, PhD

CONTACT

[email protected]

+55 34 3239-4761

Adriano Andrade, PhD

CONTACT

[email protected]

+ 34 3239-4761

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Collaborators

  • 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
  • Núcleo de Inovação e Avaliação Tecnológica em Saúde

Registry information

Important dates

Study start
2025
Primary completion
2034
Study completion
2034
First posted
Aug 2, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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