Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension
- Conditions
- Parkinson DiseaseOrthostatic Hypotension
- Registration Number
- NCT07139756
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- 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
Phase 2:
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
- Dementia
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences and changes in BOLD fMRI signal intensity 1.5 hour Changes in brain BOLD fMRI signal in the dorsolateral medulla of the brainstem in response to LBNP
- Secondary Outcome Measures
Name Time Method Functional connectivity 1.5 hour Activation patterns in spatially separated brain regions tending to have synchronous activity in resting state and activation pattern change during LBNP
Structural connectivity 30 minutes Map of anatomical (neural) connections within the brain in PD patients with and without OH
Contrast-enhanced renal ultrasound 1.5 hour Changes in renal perfusion in response to LBNP
pre-cerebral blood flow 30 minutes changes in pre-cerebral blood flow in response to LBNP
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Vaud, Switzerland
Centre Hospitalier Universitaire Vaudois🇨🇭Lausanne, Vaud, Switzerland