Effects of Blood Pressure on Cognition and Cerebral Blood Flow in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Delis-Kaplan Executive Function System Verbal Fluency Test score (number of words per minute). Minimum: 0; Maximum: N/A; higher is better
研究概览
简要总结
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.
详细描述
After reviewing and signing an IRB-approved informed consent, participants will undergo the following clinical assessments for the Screening Visit (duration 3 hours), to determine eligibility:
- complete medical and surgical history including current medication and substance use
- general physical and neurological exam
- a tilt table test to confirm presence or absence of orthostatic hypotension (OH) OH (defined as systolic BP drop of > 20mmHg or diastolic BP drop of > 10mmHg within 3 minutes of head-up tilt, per consensus criteria (Gibbons et al., 2017)
- Orthostatic Hypotension Questionnaire (OHQ) (contains 6 items assessing OH symptoms and 4 items assessing OH symptom burden on daily activities)
- Movement Disorders Society Unified Parkinson's Disease Rating Scale
- Geriatric Depression Scale
- head circumference measurements to plan for optimal fitting of the functional near-infrared spectroscopy cap
- a reading test
- a cognitive test
Baseline Study Visit Procedures: If participants meet all eligibility criteria, after undergoing the screening visit, they will later attend a baseline study visit (duration about 3 hours), which will occur on a separate day.
Participants will be instructed to eat a small meal on the day of the visit, abstain from caffeine for 24 hours, and to take all home medications as prescribed. Participants will be encouraged to bring any prescribed antiparkinsonian medications with them to the study visit if it coincides with their usual dosing time, since fluctuations in dopaminergic medications could impact cognitive performance. Upon arrival, participants will complete the Orthostatic Hypotension Questionnaire (OHQ).
Continuous Non-Invasive BP Monitoring: The CareTaker® is a Food and Drug Administration (FDA)-approved continuous, non-invasive, beat-to-beat BP monitor. This device is worn around the wrist like a watch and uses a sensor attached to an inflatable finger cuff to measure BP by detecting arterial pulsations beneath the skin. The device can continuously monitor BP for up to 24 hours in the ambulatory setting with wireless Internet connection. 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. At the start of the visit, the CareTaker® will be placed on the participant's hand that has the least involuntary movement, (e.g., tremor or dyskinesia) to minimize any motion artifact. The BP monitor will be worn during the entire visit and will be removed at the end of the visit. The start and end time of each cognitive task will be recorded and will be time- stamped with an event marker on the Caretaker® to correlate BP with each cognitive task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson Disease using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria
- •Age at least 50 years old
- •Hoehn & Yahr (H&Y) stages I-III (early to moderate-stage PD; able to walk without assistance
- •Proficiency in the English language (native English speaker level)
排除标准
- •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
- •Dementia (including PD dementia)
- •History of deep brain stimulation (DBS) surgery
- •Any current unstable, active medical problem, e.g. decompensated heart failure, liver failure, pneumonia, etc.
- •Moderate or severe carotid artery stenosis (according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria
- •History of cerebral infarction or hemorrhage
- •Uncontrolled diabetes or any other systemic disease causing autonomic failure
- •Syncope (fainting) within the past week
- •Illiteracy (unable to read)
- •Taking antihypertensive medications or alpha-adrenergic blocking medications, since these can cause hypotension (see * below)
- •Impairment of hearing or vision that is not corrected by devices (e.g., hearing aids or glasses)
- •Currently pregnant (will be confirmed by women of child-bearing potential with a urine pregnancy test)
- •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.
研究组 & 干预措施
Supine cognitive testing first
The cognitive testing sessions will be alternated between supine and upright positions.
This group will perform cognitive testing sessions in the following order: 1) supine, 2) upright, 3) supine, 4) upright.
干预措施: Tilt table (upright position) (Diagnostic Test)
Upright cognitive testing first
The cognitive testing sessions will be alternated between supine and upright positions.
This group will perform cognitive testing sessions in the following order: 1) upright, 2) supine, 3) upright, 4) supine.
干预措施: Tilt table (upright position) (Diagnostic Test)
结局指标
主要结局
Delis-Kaplan Executive Function System Verbal Fluency Test score (number of words per minute). Minimum: 0; Maximum: N/A; higher is better
时间窗: up to 30 months
Participant says as many words in 1 minute as possible each of several letter or category prompts.
Oxygenated and deoxygenated hemoglobin change from baseline
时间窗: up to 30 months
Functional near-infrared spectroscopy will measure relative changes in oxygenated and deoxygenated hemoglobin variables
次要结局
未报告次要终点
研究者
Katie Longardner
Assistant Clinical Professor of Health Sciences
University of California, San Diego