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

Sponsor
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05308485
Collaborator
(none)
300
1
30.7
9.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Events Exposure as a Trigger of the Clinical Manifestations of Parkinson's Disease
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Jul 26, 2022
Anticipated Study Completion Date :
Jul 27, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Healthy individuals

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

Outcome Measures

Primary Outcome Measures

  1. Recruitment of 300 participants [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 FLENI Buenos Aires Caba Argentina 1428

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Malco Rossi, MD, PhD - Co-investigator - Clinical Professor, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
ClinicalTrials.gov Identifier:
NCT05308485
Other Study ID Numbers:
  • 3961
First Posted:
Apr 4, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022