Events Exposure as a Trigger of the Clinical Manifestations of Parkinson's Disease

NCT05308485 | Unknown DMC

• 1 other identifier: 3961
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Stress has been implicated as a trigger of many diseases, throughout different mechanisms. Potentially traumatic/stressful events exposure might be a factor that triggers subclinical disabilities related to PD becoming evident to the patient. In this observational study, the investigators will evaluate with a validated events exposure questionnaire the occurrence and severity of potentially traumatic or stressful events in Parkinson's disease patients and in patients with recent-onset parkinsonism.

Conditions

Parkinson Disease; Parkinsonism

Outcome Measures

Primary Outcomes (1)

• Recruitment of 300 participants

  36 months

Study Arms (3)

Parkinson´s disease individuals

Other: Events exposure questionnaire

Individuals with recent-onset parkinsonism

Other: Events exposure questionnaire

Healthy individuals

Other: Events exposure questionnaire

Interventions

Events exposure questionnaire OTHER

Events exposure questionnaire that assess the occurrence of exposure to events and their severity over a limited period

Healthy individuals; Individuals with recent-onset parkinsonism; Parkinson´s disease individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinically diagnosed Parkinson's Disease (PD) patients and patients with recent-onset parkinsonism

You may qualify if:

• Informed consent is obtained from the participant
• The participant is clinically diagnosed with Parkinson's disease
• The participant has recent-onset parkinsonism

You may not qualify if:

• Participants with parkinsonism with more than 4 years of evolution of the disease

Sponsors & Collaborators

• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia: lead

Study Sites (1)

FLENI

Buenos Aires, Buenos Aires F.D., 1428, Argentina

Location

Related Publications (1)

• Paez-Maggio M, Rossi M, Fazzito L, Merello M. Validation of an events exposure questionnaire for individuals living in major cities of Argentina. Eur J Psychotraumatol. 2022 Feb 15;13(1):2031830. doi: 10.1080/20008198.2022.2031830. eCollection 2022.

  PMID: 35186218 RESULT

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD - Co-investigator - Clinical Professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: January 6, 2020
• Primary Completion: July 26, 2022
• Study Completion: July 27, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)