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

NCT ID: NCT02727270

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2023-11-16

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Huntington Disease

Keywords

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Movement disorders Metabolic Stress Basal Ganglia Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson's - High Stress *FULL NOT RECRUITING

Parkinson's disease patients with self-reported high strain/stress.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Parkinson's - Low Stress *FULL NOT RECRUITING

Parkinson's disease patients with self-reported low strain/stress.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Controls - High Stress *FULL NOT RECRUITING

Healthy controls (no neurological disease) with self-reported high strain/stress.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Controls - Low Stress *FULL NOT RECRUITING

Healthy controls (no neurological disease) with self-reported low strain/stress.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Huntington's - High Stress *FULL NOT RECRUITING

Huntington's disease patients and/or Huntington's disease gene carriers with self-reported high strain/stress.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Huntington's - Low Stress *FULL NOT RECRUITING

Huntington's disease patients and/or Huntington's disease gene carriers with self-reported low strain/stress.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Parkinson's Disease - ReEnrollment (COVID-19) *FULL NOT RECRUITING

Parkinson's disease patients that had previously completed the study.

No Intervention - Observational Study

Intervention Type OTHER

No Intervention - Observational Study

Interventions

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No Intervention - Observational Study

No Intervention - Observational Study

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Portland VA Medical Center

FED

Sponsor Role collaborator

Oregon Clinical and Translational Research Institute

OTHER

Sponsor Role collaborator

Huntington's Disease Society of America

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Amie Hiller, MD

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amie L Hiller, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science Universtiy

Portland, Oregon, United States

Site Status

VA Portland Health Care System

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23078376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9263193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6067490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20129404 (View on PubMed)

Other Identifiers

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3794

Identifier Type: OTHER

Identifier Source: secondary_id

5338

Identifier Type: OTHER

Identifier Source: secondary_id

4546

Identifier Type: OTHER

Identifier Source: secondary_id

7186

Identifier Type: OTHER

Identifier Source: secondary_id

15183

Identifier Type: -

Identifier Source: org_study_id