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Blood Pressure Effects on Cognition and Brain Blood Flow in PD

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Questionnaires, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The proposed experiments will measure BP and brain blood flow continuously in real-time using innovative wearable technology."
  • "Orthostatic Hypotension Questionnaire (OHQ) (contains 6 items assessing OH symptoms and 4 items assessing OH symptom burden on daily activities) 5."
  • "Upon arrival, participants will complete the Orthostatic Hypotension Questionnaire (OHQ)."
  • "The CareTaker® uses Bluetooth technology to transmit BP data to a paired electronic Android tablet, automatically logging and documenting BP parameters and waveforms."
  • "Data can be accessed immediately on the tablet. variables that will be analyzed."
  • "Functional near-infrared spectroscopy (fNIRS) is a non-invasive, wearable technology that applies distinct near-infrared light wavelengths into the scalp to measure changes in the color of blood, since oxy- hemoglobin (HbO) absorbs light differently than deoxy-hemoglobin (Hb)."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how blood pressure affects thinking and blood flow in the brain in people with Parkinson’s disease. It is for adults age 50 or older, with or without low blood pressure when standing. Participants will wear sensors and take thinking tests while lying down and upright.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have idiopathic Parkinson’s disease, meaning its cause is unknown, diagnosed using standard guidelines.
  • Be age 50 or older.
  • Have early to moderate Parkinson’s disease and be able to walk without help.
  • Speak English at the level of a native speaker.

Who can't join

  • Have shaking or other unwanted movements larger than 3 centimeters (about 1 inch). Movements controlled with medicine may be allowed.
  • Have dementia, a history of stroke or bleeding in the brain, or past deep brain stimulation surgery.
  • Have a current, unstable illness, such as heart failure, liver failure, or pneumonia; or another condition the study doctor thinks makes participation unsafe.
  • Have moderate or severe narrowing of the neck arteries that supply the brain, uncontrolled diabetes, or another body-wide disease that damages automatic controls such as blood pressure.
  • Have fainted in the past week or are currently pregnant.
  • Cannot read, or have hearing or vision problems that hearing aids or glasses do not correct.
  • Take certain medicines for high blood pressure, water pills, or listed medicines for an enlarged prostate. If you take these, discuss with your prescribing doctor whether you may stop them for 48 hours before the visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

CA