PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil
- Conditions
- Parkinson Disease
- Registration Number
- NCT06536348
- Lead Sponsor
- Federal University of Uberlandia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 958
- 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.
For both groups, individuals who have other neurological or musculoskeletal diseases that interfere with the execution of the tests will be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Date of diagnosis related to the primary ICD 10 years date
Length of schooling 10 years Length of schooling in years
Height 10 years Height in cm
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
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
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
Blood type 10 years Blood type: A+, A-, B+, B-, O+, O-, AB+, AB-
Current city of residence 10 years City of residence in Brazil
Sex 10 years Sex: male, female
Age 10 years Age in years
Weight 10 years Weight in kg
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
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.
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.Visual Acuity 10 years Visual Acuity measured according to the Snellen test (https://www.ncbi.nlm.nih.gov/books/NBK558961/)
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
Current state of residence 10 years State of residence in Brazil
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.Civil status 10 years married, single, divorced, and widowed
Occupation 10 years Profession according to the Brazilian Classification of Occupation (https://www.mtecbo.gov.br/cbosite/pages/home.jsf)
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)
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)
Household size 10 years The number of adults and children living in a home
Monthly wage 10 years Monthly wage in Brazilian Reais
Head movement amplitude 10 years Head movement amplitude in degrees
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)
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).
Head movement speed 10 years Head movement speed in degrees per second
Handwriting movement analysis 10 years Handwriting speed (seconds) and quality
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.Hand movement 10 years Hand movement in degrees per second
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Centro Universitário Araguaia (UniAraguaia)
🇧🇷Goiânia, Goiás, Brazil
Laboratório de Análise de Movimento e Processamento de Sinais
🇧🇷Brasília, Distrito Federal, Brazil
Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia
🇧🇷Uberlândia, Minas Gerais, Brazil
Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in Health
🇧🇷Uberlândia, Minas Gerais, Brazil
Associação Parkinson Goiás
🇧🇷Goiânia, Goiás, Brazil