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

NCT ID: NCT05308485

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-07-27

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.

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.

Conditions

Parkinson Disease; Parkinsonism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Parkinson´s disease individuals

Events exposure questionnaire

Intervention Type: OTHER

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

Individuals with recent-onset parkinsonism

Events exposure questionnaire

Intervention Type: OTHER

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

Healthy individuals

Events exposure questionnaire

Intervention Type: OTHER

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

Interventions

Events exposure questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

OTHER

Sponsor Role: lead

Responsible Party

Malco Rossi

MD, PhD - Co-investigator - Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FLENI

Buenos Aires, Buenos Aires F.D., Argentina

Countries

Argentina

References

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.

Reference Type: RESULT

PMID: 35186218 (View on PubMed)

Other Identifiers

3961

Identifier Type: -

Identifier Source: org_study_id