NCT07139756尚未招募不适用
Deciphering the Mechanisms of Central Blood Pressure Regulation in Patients With Parkinson Disease Associated With Orthostatic Hypotension: A 2-phase Observational Study With Healthy Participants and Patients With Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Differences and changes in BOLD fMRI signal intensity
研究概览
简要总结
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants.
Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
详细描述
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants using BOLD fMRI
Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
Phase 2 secondary objectives:
- assess modulation of functional connectivity in response to LBNP (effective connectivity analysis by psycho-physiological interactions (PPI)) and determine differences between the two groups
- assess functional connectivity in resting state and determine differences between the two groups
- compare structural connectivity in both groups using tractography
- compare renal response to LBNP in both groups using contrast-enhanced ultrasound
- compare pre-cerebral flow response to LBNP in both groups
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Age ≥ 18 years and <75 years
- •Normal office blood pressure (<140/90 mmHg)
- •For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
排除标准
- •Schellong test showing OH (drop of Systolic BP >20 mmHg or Diastolic BP >10 mmHg)
- •Pregnant or lactating women
- •Refusal to be informed of incidental findings
- •Any medication (acute or chronic prescription) except oral contraception
- •Clinical significant abnormal blood test as assessed by the investigator
- •Chronic or acute illness
- •Concomitant participation in a clinical trial
- •Blood donation in the 60 previous days
- •Contra-indications for MRI
- •Unable to follow study procedures
- •Having a hierarchical relationship with the investigator or being family of the investigator
- •Inclusion Criteria:
- •Signed informed consent
- •Fulfilling Movement Disorder Society clinical criteria for "clinically established PD"
- •Age ≥18 years and <75 years
- •PD treated by dopamine replacement therapy (DRT)
- •Willing and able to comply with the visit schedule and study procedures
- •Autonomous in daily life
- •Schellong test showing OH (drop of Systolic BP >20 mmHg or Diastolic BP >10 mmHg)(for study group with OH) or no OH (for studygroup without OH)
- •For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
- •Exclusion Criteria:
- •Unable to give an informed consent
- •BP > 180/110 mmHg on 24-hour ambulatory blood pressure monitoring
- •eGFR < 45 ml/min/1.73 ml/min/m2 by CKD-EPI equation
- •having contra-indications for MRI
- •Pregnant or lactating women
- •Refusal to be informed of incidental findings
- •Allergy to components of contrast agent Sonovue®
- •Living in an institution
- •Type 2 diabetes
- •Stroke or myocardial infarction in the past 6 months
- •Blood donation in the previous 6 months
- •Active oncology treatment
- •Having a hierarchical relationship with the investigator or being family of the investigator
结局指标
主要结局
Differences and changes in BOLD fMRI signal intensity
时间窗: 1.5 hour
Changes in brain BOLD fMRI signal in the dorsolateral medulla of the brainstem in response to LBNP
次要结局
- Functional connectivity(1.5 hour)
- Structural connectivity(30 minutes)
- Contrast-enhanced renal ultrasound(1.5 hour)
- pre-cerebral blood flow(30 minutes)
研究者
Gregoire Wuerzner; MD
Principal Investigator
Centre Hospitalier Universitaire Vaudois
研究点 (1)
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