Clinical trial NCT02727270: Measuring Cortisol Levels in Persons With Parkinson's (PD)
Official title: Measuring Cortisol Levels in Persons With Parkinson's (PD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Huntington Disease
Keywords: Movement disorders
Metabolic Stress
Basal Ganglia Disorders
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
name: Oregon Clinical and Translational Research Institute
name: Huntingtons Disease Society of America (HDSA)
First posted: 2016-04-04
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Awakening Salivary Cortisol level (ug/dL) Response
timeFrame: Collected upon awakening and 30 minutes after awakening
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science Universtiy
state: Oregon
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Amie L Hiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.