PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 958
- 试验地点
- 10
- 主要终点
- Date of diagnosis related to the primary ICD
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •For both groups, individuals who have other neurological or musculoskeletal diseases that interfere with the execution of the tests will be excluded.
研究组 & 干预措施
Experimental group
Group of subjects with Parkinson's disease
Control group
Neurological healthy subjects
结局指标
主要结局
Date of diagnosis related to the primary ICD
时间窗: 10 years
date
Height
时间窗: 10 years
Height in cm
Medications in use
时间窗: 10 years
name and daily dose of medications
Family history related to the primary ICD
时间窗: 10 years
Is there family history related to the primary ICD? (yes, no)
Date of symptom onset related to the primary ICD
时间窗: 10 years
date
Primary ICD
时间窗: 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
Sex
时间窗: 10 years
Sex: male, female
Age
时间窗: 10 years
Age in years
Length of schooling
时间窗: 10 years
Length of schooling in years
Blood type
时间窗: 10 years
Blood type: A+, A-, B+, B-, O+, O-, AB+, AB-
Current city of residence
时间窗: 10 years
City of residence in Brazil
Weight
时间窗: 10 years
Weight in kg
Housing classification
时间窗: 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
时间窗: 10 years
Verification if the participant has had contact with one of the following devices: mobile, personal computer, mouse, webcam, keyboard, microphone, earphone.
Visual Acuity
时间窗: 10 years
Visual Acuity measured according to the Snellen test (https://www.ncbi.nlm.nih.gov/books/NBK558961/)
Secondary ICDs
时间窗: 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
时间窗: 10 years
State of residence in Brazil
Civil status
时间窗: 10 years
married, single, divorced, and widowed
Occupation
时间窗: 10 years
Profession according to the Brazilian Classification of Occupation (https://www.mtecbo.gov.br/cbosite/pages/home.jsf)
Facial expression
时间窗: 10 years
Facial expression evaluation according to the Facial Action Coding System (FACS)
Saccadic eye movement
时间窗: 10 years
Speed and regularity of eye movement (degrees per second and latency in ms)
Dysarthria
时间窗: 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
时间窗: 10 years
The number of adults and children living in a home
Monthly wage
时间窗: 10 years
Monthly wage in Brazilian Reais
Head movement amplitude
时间窗: 10 years
Head movement amplitude in degrees
Smooth pursuit eye movement
时间窗: 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
时间窗: 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
时间窗: 10 years
Head movement speed in degrees per second
Handwriting movement analysis
时间窗: 10 years
Handwriting speed (seconds) and quality
Cognition
时间窗: 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
时间窗: 10 years
Hand movement in degrees per second
Economic Rating Score
时间窗: 10 years
Economic rating as given by the Brazilian Economic Classification Criteria (Brazilian Criteria) - https://www.abep.org/criterioBr/01\_cceb\_2022\_eng.pdf
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Adriano de Oliveira Andrade
Professor
Federal University of Uberlandia