Effects of Blood Pressure on Thinking and Brain Blood Flow in Parkinson's Disease
Effects of Blood Pressure on Cognition and Cerebral Blood Flow in Parkinson Disease
This study is testing how low blood pressure affects thinking and blood flow in the brains of people with Parkinson's disease who have trouble standing up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05400174 on ClinicalTrials.gov |
What this trial studies
This study investigates how blood pressure affects cognitive function and brain blood flow in individuals with Parkinson's disease (PD) who also experience orthostatic hypotension (OH). Participants will undergo a series of clinical assessments, including a tilt table test to confirm the presence of OH and various cognitive evaluations. The goal is to understand the relationship between low blood pressure and cognitive issues that occur when standing, which may not present with typical symptoms. This research aims to identify potential treatment strategies for managing OH in PD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and older with a diagnosis of idiopathic Parkinson's disease in early to moderate stages.
Not a fit: Patients with severe involuntary movements, dementia, or those who have undergone deep brain stimulation surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cognitive symptoms in Parkinson's disease by addressing orthostatic hypotension.
How similar studies have performed: While the relationship between blood pressure and cognition in PD is being explored, this specific approach to understanding OH's impact on cognitive function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Diagnosis of idiopathic Parkinson Disease using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria
2. Age at least 50 years old
3. Hoehn \& Yahr (H\&Y) stages I-III (early to moderate-stage PD; able to walk without assistance
4. Proficiency in the English language (native English speaker level)
Exclusion Criteria:
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. Dementia (including PD dementia)
3. History of deep brain stimulation (DBS) surgery
4. Any current unstable, active medical problem, e.g. decompensated heart failure, liver failure, pneumonia, etc.
5. Moderate or severe carotid artery stenosis (according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria
6. History of cerebral infarction or hemorrhage
7. Uncontrolled diabetes or any other systemic disease causing autonomic failure
8. Syncope (fainting) within the past week
9. Illiteracy (unable to read)
10. Taking antihypertensive medications or alpha-adrenergic blocking medications, since these can cause hypotension (see \* below)
11. Impairment of hearing or vision that is not corrected by devices (e.g., hearing aids or glasses)
12. Currently pregnant (will be confirmed by women of child-bearing potential with a urine pregnancy test)
13. Any other condition, which, in the opinion of the investigator, could place the participant at increased risk.
* Please note that persons may not participate if they are taking any of the following:
* medications to treat high blood pressure (called "antihypertensives") such as clonidine (Catapres), hydralazine, verapamil, diltiazem (Cartia), or medications ending in "-olol", "-artan", or "-pril")
* diuretics (also called "water pills") such as furosemide (Lasix), bumetanide (Bumex), hydrochlorothiazide (HCTZ; Microzide), or spironolactone (Aldactone)
* medications for enlarged prostate such as prazosin (Minipress), terazosin, doxazosin (Cardura), alfuzosin (Uroxatral), or tamsulosin (Flomax)
If persons are taking these medications and would like to participate in the study, they will be advised to discuss whether they may discontinue these medications for 48 hours before the study visit with their prescribing doctor.
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Katherine Longardner, MD
- Email: klongardner@health.ucsd.edu
- Phone: 8588225751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.