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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Sex — 10 years
  Sex: male, female
• Age — 10 years
  Age in years
• Length of schooling — 10 years
  Length of schooling in years
• Weight — 10 years
  Weight in kg
• Height — 10 years
  Height in cm
• Blood type — 10 years
  Blood type: A+, A-, B+, B-, O+, O-, AB+, AB-
• Economic Rating Score — 10 years
  Economic rating as given by the Brazilian Economic Classification Criteria (Brazilian Criteria) - https://www.abep.org/criterioBr/01\_cceb\_2022\_eng.pdf
• Primary ICD — 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
• Secondary ICDs — 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
• Medications in use — 10 years
  name and daily dose of medications
• Family history related to the primary ICD — 10 years
  Is there family history related to the primary ICD? (yes, no)
• Date of symptom onset related to the primary ICD — 10 years
  date
• Date of diagnosis related to the primary ICD — 10 years
  date
• Current city of residence — 10 years
  City of residence in Brazil
• Current state of residence — 10 years
  State of residence in Brazil
• Civil status — 10 years
  married, single, divorced, and widowed
• Housing classification — 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
• Household size — 10 years
  The number of adults and children living in a home
• Laterality — 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).
• Use of technology — 10 years
  Verification if the participant has had contact with one of the following devices: mobile, personal computer, mouse, webcam, keyboard, microphone, earphone.
• Occupation — 10 years
  Profession according to the Brazilian Classification of Occupation (https://www.mtecbo.gov.br/cbosite/pages/home.jsf)
• Monthly wage — 10 years
  Monthly wage in Brazilian Reais
• Head movement amplitude — 10 years
  Head movement amplitude in degrees
• Head movement speed — 10 years
  Head movement speed in degrees per second
• Facial expression — 10 years
  Facial expression evaluation according to the Facial Action Coding System (FACS)
• Saccadic eye movement — 10 years
  Speed and regularity of eye movement (degrees per second and latency in ms)
• Smooth pursuit eye movement — 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)
• Handwriting movement analysis — 10 years
  Handwriting speed (seconds) and quality
• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) — 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.
• Depression — 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.
• Visual Acuity — 10 years
  Visual Acuity measured according to the Snellen test (https://www.ncbi.nlm.nih.gov/books/NBK558961/)
• Cognition — 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.
• Dysarthria — 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)
• Hand movement — 10 years
  Hand movement in degrees per second

Trial sites (5)

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