RECRUITING

Blood Pressure Effects on Cognition and Brain Blood Flow in PD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Parkinson's disease (PD) is the second most common neurodegenerative disorder worldwide. Besides causing symptoms that impair movement, PD also causes non-motor symptoms, such as problems thinking and orthostatic hypotension (OH), i.e., low blood pressure (BP) when standing. About one-third of people with PD have OH, which can cause sudden, temporary symptoms while upright, including lightheadedness, dizziness, and fainting. People with PD and OH can also experience problems thinking that happen only while upright and not while sitting - this can occur without other symptoms, such as feeling dizzy or faint. However, the level of low BP that can affect thinking remains unknown, and no guidelines exist for treating OH when it happens without symptoms. This is significant because OH could be a treatable risk factor for thinking problems in PD, but OH is often not treated if people do not report obvious symptoms. This project's goal is to determine how BP affects brain function in PD. The proposed experiments will measure BP and brain blood flow continuously in real-time using innovative wearable technology. Persons with PD with OH and without OH will undergo repeated cognitive tests while supine (lying down) and while upright. I will study the associations between BP, thinking abilities, and brain blood flow, and will compare groups with and without OH. These findings could be important because if a certain level of BP correlates with thinking abilities, then treating OH in PD may prevent thinking problems, which would improve health-related quality of life and reduce disability and healthcare costs.

Official Title

Effects of Blood Pressure on Cognition and Cerebral Blood Flow in Parkinson Disease

Quick Facts

Study Start:2021-12-14
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05400174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of idiopathic Parkinson Disease using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria
  2. 2. Age at least 50 years old
  3. 3. Hoehn \& Yahr (H\&Y) stages I-III (early to moderate-stage PD; able to walk without assistance
  4. 4. Proficiency in the English language (native English speaker level)
  1. 1. Any involuntary movements (i.e., tremor or dyskinesia) \> 3 cm in amplitude (ok if movements are treated with medication), since the motion artifact could interfere with blood pressure monitor data collection
  2. 2. Dementia (including PD dementia)
  3. 3. History of deep brain stimulation (DBS) surgery
  4. 4. Any current unstable, active medical problem, e.g. decompensated heart failure, liver failure, pneumonia, etc.
  5. 5. Moderate or severe carotid artery stenosis (according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria
  6. 6. History of cerebral infarction or hemorrhage
  7. 7. Uncontrolled diabetes or any other systemic disease causing autonomic failure
  8. 8. Syncope (fainting) within the past week
  9. 9. Illiteracy (unable to read)
  10. 10. Taking antihypertensive medications or alpha-adrenergic blocking medications, since these can cause hypotension (see \* below)
  11. 11. Impairment of hearing or vision that is not corrected by devices (e.g., hearing aids or glasses)
  12. 12. Currently pregnant (will be confirmed by women of child-bearing potential with a urine pregnancy test)
  13. 13. Any other condition, which, in the opinion of the investigator, could place the participant at increased risk.
  14. * Please note that persons may not participate if they are taking any of the following:
  15. * medications to treat high blood pressure (called "antihypertensives") such as clonidine (Catapres), hydralazine, verapamil, diltiazem (Cartia), or medications ending in "-olol", "-artan", or "-pril")
  16. * diuretics (also called "water pills") such as furosemide (Lasix), bumetanide (Bumex), hydrochlorothiazide (HCTZ; Microzide), or spironolactone (Aldactone)
  17. * medications for enlarged prostate such as prazosin (Minipress), terazosin, doxazosin (Cardura), alfuzosin (Uroxatral), or tamsulosin (Flomax)

Contacts and Locations

Study Contact

Katherine Longardner, MD
CONTACT
8588225751
klongardner@health.ucsd.edu
Michael Skipworth, BS
CONTACT
8588225751
mskipworth@health.ucsd.edu

Study Locations (Sites)

University of California San Diego
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-14
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2021-12-14
Study Completion Date2025-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Orthostatic Hypotension
  • Dysautonomia