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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Parkinsonism
• Intervention / Treatment: Other: Events exposure questionnaire

Detailed Description

Parkinson's disease (PD) is one of the most common neurodegenerative disorders worldwide, affecting approximately 1% of individuals older than 60 years and causing progressive disability. Clinical signs and symptoms of PD include asymmetric bradykinesia, rest tremor, rigidity, postural instability, and gait abnormalities.

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. Stress or events exposure can be associated with the clinical expression of Parkinson's sisease, acting as the final hit in a predisposed person. The prevalence of exposure to traumatic events (TE) throughout life in different populations has been analyzed in multiple studies, with variable percentages, ranging from 30 -70%.

It is well known that stress activates both the sympathetic nervous system and the hypothalamic - pituitary - adrenal (HPA) axis, resulting in increases in the secretion of catecholamines and glucocorticoids (GCs) into the peripheral circulation. Stress also can increase the release of dopamine (DA) and glutamate in the striatum as well as other brain regions. It is likely that these effects of stress have evolved as part of a generalized response to potential danger, facilitating the ability of the organism to respond appropriately to the stressor. More specifically, given the impact of DA and glutamate on striatal function, these changes can be expected to increase the capacity of the CNS to focus, process, and ultimately respond appropriately to emergencies. These effects are likely to be reinforced by the increased availability of GCs. Yet, when the amplitude or duration of these biological changes becomes excessive, the possibility of neuronal cell death develops. The greatest risk factor for PD appears to be age. The tendency for the symptoms of PD to emerge after the age of 55 may be due in part to a failure of compensatory mechanisms that underlie the extended preclinical phase of the disease. However, it is likely that another factor in the late onset of PD is the increased vulnerability of DA neurons to insult. In this regard, it is important to note that dysfunctions in the stress response develop during the aging process. For example, as organism ages, the response of the HPA axis to stress becomes hyperactive and is slower to return to homeostatic conditions after activation, thus exposing cells to higher levels of GCs for a prolonged period. This dysregulation might render cells in the aged brain more susceptible to degeneration in the face of subsequent stress.

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Argentina
  • Caba
    • Buenos Aires, Caba, Argentina, 1428
      • FLENI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy individuals	Other: Events exposure questionnaire; Events exposure questionnaire that assess the occurrence of exposure to events and their severity over a limited period
Parkinson´s disease individuals	Other: Events exposure questionnaire; Events exposure questionnaire that assess the occurrence of exposure to events and their severity over a limited period
Individuals with recent-onset parkinsonism	Other: Events exposure questionnaire; Events exposure questionnaire that assess the occurrence of exposure to events and their severity over a limited period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recruitment of 300 participants	36 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): July 26, 2022
• Study Completion (Anticipated): July 27, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: 3961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan will be defined at a later stages

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No