Parkinson DiseaseCORT-PDNCT02727270
Measuring Cortisol Levels in Persons With Parkinson's (PD)
An observational study of Parkinson Disease and Huntington Disease, run by Oregon Health and Science University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Huntington Disease
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to 16 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- Group (6) Inclusion:
- HD diagnosis or HD gene carrier
- PSS score lower than 13
- Group (7) Inclusion:
- PD diagnosis
- Prior completion of the study.
Who cannot join
- The use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health & Science Universtiy
Portland, Oregon, 97239
VA Portland Health Care System
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Huntington Disease
- Being tested
- No Intervention - Observational Study
- Keywords
- Movement disorders, Metabolic Stress, Basal Ganglia Disorders
- Medical subject headings
- Parkinson Disease, Huntington Disease, Movement Disorders, Basal Ganglia Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention - Observational StudyOther
No Intervention - Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's - High Stress *FULL NOT RECRUITING | Parkinson's disease patients with self-reported high strain/stress. Receives: Other: No Intervention - Observational Study | |
| Parkinson's - Low Stress *FULL NOT RECRUITING | Parkinson's disease patients with self-reported low strain/stress. Receives: Other: No Intervention - Observational Study | |
| Controls - High Stress *FULL NOT RECRUITING | Healthy controls (no neurological disease) with self-reported high strain/stress. Receives: Other: No Intervention - Observational Study | |
| Controls - Low Stress *FULL NOT RECRUITING | Healthy controls (no neurological disease) with self-reported low strain/stress. Receives: 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. Receives: 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. Receives: Other: No Intervention - Observational Study | |
| Parkinson's Disease - ReEnrollment (COVID-19) *FULL NOT RECRUITING | Parkinson's disease patients that had previously completed the study. Receives: Other: No Intervention - Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collected upon awakening and 30 minutes after awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center, Oregon Clinical and Translational Research Institute, Huntington's Disease Society of America
- Responsible party
- Principal investigator, Amie Hiller, MD, Oregon Health and Science University
- Investigators
- Amie L Hiller, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727270
- Sponsor's protocol ID
- 15183
- Other IDs
- 3794, 5338, 4546, 7186
- Acronym
- CORT-PD
- Status last verified
- Dec 2023
- First submitted
- 21 Mar 2016
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23078376Hartmann 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.
PubMed 9263193Marsden 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.
PubMed 6067490Matousek 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.
PubMed 20129404
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cortisol Levels in Persons With Parkinson's (PD)
- ClinicalTrials.gov ID
- NCT02727270
- Acronym / sponsor ID
- CORT-PD / 15183
- Conditions
- Parkinson Disease, Huntington Disease
- Keywords
- Movement disorders, Metabolic Stress, Basal Ganglia Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland VA Medical Center, Oregon Clinical and Translational Research Institute, Huntington's Disease Society of America
- Study start
- Jun 2016
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Parkinson's - High Stress *FULL NOT RECRUITING | – | Other: No Intervention - Observational StudyParkinson's disease patients with self-reported high strain/stress. |
| Parkinson's - Low Stress *FULL NOT RECRUITING | – | Other: No Intervention - Observational StudyParkinson's disease patients with self-reported low strain/stress. |
| Controls - High Stress *FULL NOT RECRUITING | – | Other: No Intervention - Observational StudyHealthy controls (no neurological disease) with self-reported high strain/stress. |
| Controls - Low Stress *FULL NOT RECRUITING | – | Other: No Intervention - Observational StudyHealthy controls (no neurological disease) with self-reported low strain/stress. |
| Huntington's - High Stress *FULL NOT RECRUITING | – | Other: No Intervention - Observational StudyHuntington's disease patients and/or Huntington's disease gene carriers with self-reported high strain/stress. |
| Huntington's - Low Stress *FULL NOT RECRUITING | – | Other: No Intervention - Observational StudyHuntington'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 | – | Other: No Intervention - Observational StudyParkinson's disease patients that had previously completed the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- The use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention - Observational StudyNo Intervention - Observational Study | Other | Controls - High Stress *FULL NOT RECRUITING, Controls - Low Stress *FULL NOT RECRUITING, Huntington's - High Stress *FULL NOT RECRUITING, Huntington's - Low Stress *FULL NOT RECRUITING, Parkinson's - High Stress *FULL NOT RECRUITING, Parkinson's - Low Stress *FULL NOT RECRUITING, Parkinson's Disease - ReEnrollment (COVID-19) *FULL NOT RECRUITING |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Background: PubMed 23078376Ceravolo 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.
- Background: PubMed 9263193Hartmann 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.
- Background: PubMed 6067490Marsden 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.
- Background: PubMed 20129404Matousek 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amie L Hiller, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Huntington Disease, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awakening Salivary Cortisol level (ug/dL) Response (time frame: Collected upon awakening and 30 minutes after awakening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727270, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.