- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05308485
Events Exposure as a Trigger of the Clinical Manifestations of Parkinson's Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Caba
-
Buenos Aires, Caba, Argentina, 1428
- FLENI
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Sunde individer
|
Events exposure questionnaire that assess the occurrence of exposure to events and their severity over a limited period
|
|
Parkinson´s disease individuals
|
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 that assess the occurrence of exposure to events and their severity over a limited period
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Recruitment of 300 participants
Tidsramme: 36 months
|
36 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3961
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Parkinsons sygdom
-
University of LahoreAfsluttet
-
Abbott Medical DevicesBaylor College of Medicine; University of HoustonAfsluttet
-
Bial - Portela C S.A.Afsluttet
-
CND Life SciencesDigestive Disease Associates of CTRekrutteringParkinsons sygdom | Parkinson | PARKINSON SYGGE (lidelse) | Parkinsons sygdomForenede Stater
-
Danish Research Centre for Magnetic ResonanceUniversity Hospital Bispebjerg and FrederiksbergRekrutteringSund og rask | Parkinson | Administration af medicinDanmark
-
Mayo ClinicAfsluttet
-
iRegene Therapeutics Co., Ltd.RekrutteringEn fase I/III klinisk undersøgelse til evaluering af NouvNeu001-injektion til multippel systematrofiMultipel systematrofi - Parkinson subtype (MSA-P)Kina
-
Bezmialem Vakif UniversityRekrutteringParkinsons sygdom | Parkinson | Parkinsons sygdom (PD) | PARKINSON SYGGE (lidelse) | Parkinsons sygdomTyrkiet (Türkiye)
-
CND Life SciencesOregon Health and Science UniversityRekrutteringParkinsons sygdom | Parkinson | Parkinsons sygdom og Parkinsonisme | PARKINSON SYGGE (lidelse)Forenede Stater
-
AstraZenecaParexelRekrutteringAvancerede solide tumorerSpanien, Forenede Stater, Sydkorea, Det Forenede Kongerige
Kliniske forsøg med Events exposure questionnaire
-
University of WashingtonNational Institute of Neurological Disorders and Stroke (NINDS); Gillette...AfsluttetCerebral PareseForenede Stater
-
Hospices Civils de LyonAfsluttetPost traumatisk stress syndromFrankrig
-
University at BuffaloAfsluttetArytmi, hjertebanken, svimmelhedForenede Stater
-
Africa Institute of Mental and Brain Health (AFRIMEB)National Institute of Mental Health (NIMH)Ikke rekrutterer endnuStress (psykologi) | Klima forandring | Intim partnervold (IPV)
-
Azienda Unita Sanitaria Locale Reggio EmiliaAfsluttet
-
University of Mississippi Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD); National...Ikke rekrutterer endnu
-
Case Comprehensive Cancer CenterRekruttering
-
Korea University Guro HospitalUkendtSkizofreni | Skizoaffektiv lidelseKorea, Republikken
-
Jagiellonian UniversityRekruttering
-
Jagiellonian UniversityRekruttering