Clinical trial NCT06536348: PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil
Official title: PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson's disease
motor assessment
non-motor assessment
database
computer vision
inertial sensors
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
Collaborators: name: Núcleo de Inovação e Avaliação Tecnológica em Saúde
name: Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia
name: Associação Parkinson Goiás
name: Centro Universitário Araguaia (UniAraguaia)
name: Laboratório de Análise de Movimento e Processamento de Sinais
First posted: 2024-08-02
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Experimental group: Individuals diagnosed with Parkinson's disease
* Control group: Individuals not having Parkinson's disease (PD) or other neurological disease that resembles PD;

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sex
timeFrame: 10 years
measure: Age
timeFrame: 10 years
measure: Length of schooling
timeFrame: 10 years
measure: Weight
timeFrame: 10 years
measure: Height
timeFrame: 10 years
measure: Blood type
timeFrame: 10 years
measure: Economic Rating Score
timeFrame: 10 years
measure: Primary ICD
timeFrame: 10 years
measure: Secondary ICDs
timeFrame: 10 years
measure: Medications in use
timeFrame: 10 years
measure: Family history related to the primary ICD
timeFrame: 10 years
measure: Date of symptom onset related to the primary ICD
timeFrame: 10 years
measure: Date of diagnosis related to the primary ICD
timeFrame: 10 years
measure: Current city of residence
timeFrame: 10 years
measure: Current state of residence
timeFrame: 10 years
measure: Civil status
timeFrame: 10 years
measure: Housing classification
timeFrame: 10 years
measure: Household size
timeFrame: 10 years
measure: Laterality
timeFrame: 10 years
measure: Use of technology
timeFrame: 10 years
measure: Occupation
timeFrame: 10 years
measure: Monthly wage
timeFrame: 10 years
measure: Head movement amplitude
timeFrame: 10 years
measure: Head movement speed
timeFrame: 10 years
measure: Facial expression
timeFrame: 10 years
measure: Saccadic eye movement
timeFrame: 10 years
measure: Smooth pursuit eye movement
timeFrame: 10 years
measure: Handwriting movement analysis
timeFrame: 10 years
measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 10 years
measure: Depression
timeFrame: 10 years
measure: Visual Acuity
timeFrame: 10 years
measure: Cognition
timeFrame: 10 years
measure: Dysarthria
timeFrame: 10 years
measure: Hand movement
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Laboratório de Análise de Movimento e Processamento de Sinais
state: Distrito Federal
city: Goiânia
country: Brazil
facility: Centro Universitário Araguaia (UniAraguaia)
state: Goiás
city: Goiânia
country: Brazil
facility: Associação Parkinson Goiás
state: Goiás
city: Uberlândia
country: Brazil
facility: Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia
state: Minas Gerais
city: Uberlândia
country: Brazil
facility: Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in Health
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Adriano Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
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