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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727270
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Portland VA Medical Center
Oregon Clinical and Translational Research Institute
Huntingtons Disease Society of America (HDSA)
Information provided by (Responsible Party):
Amie Hiller, MD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment
Parkinson Disease Huntington Disease Other: No Intervention - Observational Study

Detailed Description:
Telephone consent will be obtained. Participants will collect saliva at twelve time points - (four times a day for three days prior to their in-person visit). Participants will then have a half-hour in-person visit at the VA to assess stress, mood, quality of life, and Parkinson's or Huntington's.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Measuring Cortisol Levels in Persons With Parkinson's (PD)
Study Start Date : June 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
Parkinson's - High Stress
Parkinson's disease patients with self-reported high strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study

Parkinson's - Low Stress
Parkinson's disease patients with self-reported low strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study

Controls - High Stress
Healthy controls (no neurological disease) with self-reported high strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study

Controls - Low Stress
Healthy controls (no neurological disease) with self-reported low strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study

Huntington's - High Stress
Huntington's disease patients with self-reported high strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study

Huntington's - Low Stress
Huntington's disease patients with self-reported low strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study




Primary Outcome Measures :
  1. Awakening Salivary Cortisol level (ug/dL) Response [ Time Frame: Collected upon awakening and 30 minutes after awakening ]
    Salivary Cortisol level (ug/dL) Response is the change in cortisol between awakening and 30 minutes after awakening.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators plan to enroll six 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.
Criteria

Inclusion Criteria:

Group (1) Inclusion:

  • PD as confirmed by NINDS criteria
  • PD confirmed by a movement disorders specialist
  • a Perceived Stress Scale (PSS) score higher than or equal to 13.

Group (2) Inclusion:

  • PD as confirmed by NINDS criteria
  • PD confirmed by a movement disorders specialist
  • PSS score lower than 13.

Group (3) Inclusion:

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

Group (4) Inclusion:

  • No significant neurological disorder
  • PSS score of less than 13.

Group (5) Inclusion:

  • HD diagnosis
  • HD confirmed by a movement disorders specialist
  • a Perceived Stress Scale (PSS) score higher than or equal to 13.

Group (6) Inclusion:

  • HD diagnosis
  • HD confirmed by a movement disorders specialist
  • PSS score lower than 13.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727270


Contacts
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Contact: Brenna M Lobb, MS, MPH 503.220.8262 ext 51871 lobbb@ohsu.edu
Contact: Susan M O'Connor, RN 503.220.8262 ext 51091

Locations
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United States, Oregon
Oregon Health & Science Universtiy Recruiting
Portland, Oregon, United States, 97239
Contact: Brenna Lobb, MS MPH    503-220-8262 ext 51871    lobbb@ohsu.edu   
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Brenna Lobb, MS MPH    503-220-8262 ext 51871    lobbb@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center
Oregon Clinical and Translational Research Institute
Huntingtons Disease Society of America (HDSA)
Investigators
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Principal Investigator: Amie L Hiller, MD Oregon Health and Science University
Publications:
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Responsible Party: Amie Hiller, MD, Neurologist, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02727270    
Other Study ID Numbers: 15183
3794 ( Other Identifier: VA Portland Health Care System )
5338 ( Other Identifier: Oregon Clinical Translational Research Institute )
4546 ( Other Identifier: VA Portland Health Care System )
7186 ( Other Identifier: Oregon Clinical Translational Research Institute )
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.
URL: https://www.parkinsons.va.gov/northwest/
Keywords provided by Amie Hiller, MD, Oregon Health and Science University:
Movement disorders
Metabolic Stress
Basal Ganglia Disorders
Additional relevant MeSH terms:
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Parkinson Disease
Huntington Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Chorea
Dyskinesias
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders