Measuring Cortisol Levels in Persons With Parkinson's (PD)

Parkinson Disease Clinical Trial

— CORT-PD  

Official title:

Measuring Cortisol Levels in Persons With Parkinson's (PD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727270
• Other study ID #: 15183
• Secondary ID: 3794533845467186
• Status: Completed
• Start date: June 2016
• Est. completion date: November 16, 2023

Study information

• Verified date: December 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Telephone consent will be obtained. Participants will collect saliva at twelve time points - four times a day for three days. Visits will be conducted virtually (over the internet). The virtual visit is to assess Parkinson's or Huntington's disease status, stress, mood, and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Group (3) Inclusion:

• No significant neurological disorder
• PSS score of greater than or equal to 13.

Group (5) Inclusion:

• HD diagnosis or HD gene carrier
• a Perceived Stress Scale (PSS) score higher than or equal to 13.

Group (6) Inclusion:

• HD diagnosis or HD gene carrier
• PSS score lower than 13

Group (7) Inclusion:

• PD diagnosis
• Prior completion of the study.

Exclusion Criteria:

• The use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).

Related Conditions & MeSH terms

• Huntington Disease
• Parkinson Disease

Intervention

Other:
• No Intervention - Observational Study
No Intervention - Observational Study

Locations

Country	Name	City	State
United States	Oregon Health & Science Universtiy	Portland	Oregon
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	Huntingtons Disease Society of America (HDSA), Oregon Clinical and Translational Research Institute, Portland VA Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Hartmann 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. — View Citation

Marsden 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. — View Citation

Matousek 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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