Measuring Cortisol Levels in Persons With Parkinson's (PD)
CORT-PD
5 other identifiers
observational
131
1 country
2
Brief Summary
The objective of this study is to evaluate the cortisol awakening response with persons with Parkinsons Disease (PD), Huntingtons Disease (HD), and controls. These data are desired so experience can be gained with measuring stress levels subjectively and objectively in persons with PD, HD, and controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2023
CompletedDecember 22, 2023
December 1, 2023
7.5 years
March 21, 2016
December 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Awakening Salivary Cortisol level (ug/dL) Response
Salivary Cortisol level (ug/dL) Response is the change in cortisol between awakening and 30 minutes after awakening.
Collected upon awakening and 30 minutes after awakening
Study Arms (7)
Parkinson's - High Stress *FULL NOT RECRUITING
Parkinson's disease patients with self-reported high strain/stress.
Parkinson's - Low Stress *FULL NOT RECRUITING
Parkinson's disease patients with self-reported low strain/stress.
Controls - High Stress *FULL NOT RECRUITING
Healthy controls (no neurological disease) with self-reported high strain/stress.
Controls - Low Stress *FULL NOT RECRUITING
Healthy controls (no neurological disease) with self-reported low strain/stress.
Huntington's - High Stress *FULL NOT RECRUITING
Huntington's disease patients and/or Huntington's disease gene carriers with self-reported high strain/stress.
Huntington's - Low Stress *FULL NOT RECRUITING
Huntington's disease patients and/or Huntington's disease gene carriers with self-reported low strain/stress.
Parkinson's Disease - ReEnrollment (COVID-19) *FULL NOT RECRUITING
Parkinson's disease patients that had previously completed the study.
Interventions
No Intervention - Observational Study
Eligibility Criteria
The investigators plan to enroll seven groups: (1) person with PD and moderate levels of self-reported stress, (2) persons with PD and low levels of self-reported stress, (3) controls and moderate levels of self-reported stress, (4) controls and low levels of self-reported stress, (5) persons with HD and moderate/high levels of self-reported stress, and (6) persons with HD a low levels of self-reported stress, and (7) those that completed the study prior to COVID-19 restrictions in March of 2020.
You may qualify if:
- No significant neurological disorder
- PSS score of greater than or equal to 13.
- HD diagnosis or HD gene carrier
- a Perceived Stress Scale (PSS) score higher than or equal to 13.
- HD diagnosis or HD gene carrier
- PSS score lower than 13
- PD diagnosis
- Prior completion of the study.
You may not qualify if:
- The use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Portland VA Medical Centercollaborator
- Oregon Clinical and Translational Research Institutecollaborator
- Huntington's Disease Society of Americacollaborator
Study Sites (2)
Oregon Health & Science Universtiy
Portland, Oregon, 97239, United States
VA Portland Health Care System
Portland, Oregon, 97239, United States
Related Publications (4)
Ceravolo R, Frosini D, Poletti M, Kiferle L, Pagni C, Mazzucchi S, Volterrani D, Bonuccelli U. Mild affective symptoms in de novo Parkinson's disease patients: relationship with dopaminergic dysfunction. Eur J Neurol. 2013 Mar;20(3):480-485. doi: 10.1111/j.1468-1331.2012.03878.x. Epub 2012 Oct 18.
PMID: 23078376BACKGROUNDHartmann A, Veldhuis JD, Deuschle M, Standhardt H, Heuser I. Twenty-four hour cortisol release profiles in patients with Alzheimer's and Parkinson's disease compared to normal controls: ultradian secretory pulsatility and diurnal variation. Neurobiol Aging. 1997 May-Jun;18(3):285-9. doi: 10.1016/s0197-4580(97)80309-0.
PMID: 9263193BACKGROUNDMarsden CD, Owen DA. Mechanisms underlying emotional variation in parkinsonian tremor. Neurology. 1967 Jul;17(7):711-5. doi: 10.1212/wnl.17.7.711. No abstract available.
PMID: 6067490BACKGROUNDMatousek RH, Dobkin PL, Pruessner J. Cortisol as a marker for improvement in mindfulness-based stress reduction. Complement Ther Clin Pract. 2010 Feb;16(1):13-9. doi: 10.1016/j.ctcp.2009.06.004. Epub 2009 Jul 4.
PMID: 20129404BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amie L Hiller, MD
Oregon Health and Science University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurologist
Study Record Dates
First Submitted
March 21, 2016
First Posted
April 4, 2016
Study Start
June 1, 2016
Primary Completion
November 16, 2023
Study Completion
November 16, 2023
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 6 months - 2 years following article publication
- Access Criteria
- Data will be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Data will be released to achieve aims in the approved proposal or for individual participant data meta-analysis.
Individual participant data be available (including data dictionaries). Individual participant data that underlie the results reported the resultant article, after deidentification (text, tables, figures, and appendices). In addition to data, the study protocol and the informed consent form (ICF) will be provided. Data will be available beginning 6 months and ending 2 years following article publication.