PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil
NCT Number: NCT06536348
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease
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
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 958
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2034-10-01
Locations: Laboratório de Análise de Movimento e Processamento de Sinais, Brasília, Distrito Federal, 72220-275, Brazil|Centro Universitário Araguaia (UniAraguaia), Goiânia, Goiás, 74.223-060, Brazil|Associação Parkinson Goiás, Goiânia, Goiás, 74265-320, Brazil|Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia, Uberlândia, Minas Gerais, 38405-318, Brazil|Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in Health, Uberlândia, Minas Gerais, 38408-100, Brazil

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.

Primary Outcome Measures: 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