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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05308485
• Other study ID #: 3961
• Status: Active, not recruiting
• Start date: January 6, 2020
• Est. completion date: July 27, 2022

Study information

• Verified date: March 2022
• Source: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 27, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

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

Locations

Country	Name	City	State
Argentina	FLENI	Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Country where clinical trial is conducted

Argentina, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of 300 participants		36 months