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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Portland VA Medical Center | FED |
| Oregon Clinical and Translational Research Institute | OTHER |
| Huntington's Disease Society of America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's - High Stress *FULL NOT RECRUITING | Parkinson's disease patients with self-reported high strain/stress. |
| |
| Parkinson's - Low Stress *FULL NOT RECRUITING | Parkinson's disease patients with self-reported low strain/stress. |
| |
| Controls - High Stress *FULL NOT RECRUITING | Healthy controls (no neurological disease) with self-reported high strain/stress. |
| |
| Controls - Low Stress *FULL NOT RECRUITING | Healthy controls (no neurological disease) with self-reported low strain/stress. |
| |
| Huntington's - High Stress *FULL NOT RECRUITING | Huntington's disease patients and/or Huntington's disease gene carriers with self-reported high strain/stress. |
| |
| Huntington's - Low Stress *FULL NOT RECRUITING |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention - Observational Study | Other | No Intervention - Observational Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Group (3) Inclusion:
Group (5) Inclusion:
Group (6) Inclusion:
Group (7) Inclusion:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amie L Hiller, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science Universtiy | Portland | Oregon | 97239 | United States | ||
| VA Portland Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23078376 | Background | 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. | |
| 9263193 | Background |
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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.
6 months - 2 years following article publication
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.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006816 | Huntington Disease |
| D009069 | Movement Disorders |
| D001480 | Basal Ganglia Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Huntington's disease patients and/or Huntington's disease gene carriers with self-reported low strain/stress. |
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| Parkinson's Disease - ReEnrollment (COVID-19) *FULL NOT RECRUITING | Parkinson's disease patients that had previously completed the study. |
|
| Portland |
| Oregon |
| 97239 |
| United States |
| 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. |
| 6067490 | Background | 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. |
| 20129404 | Background | 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. |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |