Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension

Launched by CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS · Aug 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the brain controls blood pressure in people with Parkinson’s disease (PD), especially those who experience a condition called orthostatic hypotension (OH). OH means that when someone stands up, their blood pressure drops suddenly, which can cause dizziness or fainting. The study will use a special type of brain scan called MRI to look at how the brainstem (a part of the brain) responds to changes in blood pressure. In the first part of the study, researchers will test if a standard MRI machine can be used for this purpose. In the second part, they will compare brain responses between people with Parkinson’s who have OH and those who do not.

To take part, individuals must be adults under 75 years old with Parkinson’s disease and be able to give informed consent. For the second part of the study, participants should be living independently, treated with Parkinson’s medication, and able to follow study visits and procedures. Women who can become pregnant need to use reliable birth control during the study. Participants will undergo MRI scans and tests that involve changing blood pressure in a controlled way while their brain activity is monitored. The study is not yet recruiting, and people with certain health conditions, recent blood donations, or MRI incompatibilities won’t be eligible. This research aims to better understand blood pressure control in Parkinson’s, which could help improve care for those affected.

Gender

ALL

Eligibility criteria

• Phase 1:
• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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