Status:
NOT_YET_RECRUITING
Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
Ecole Polytechnique Fédérale de Lausanne
University Hospital, Geneva
Conditions:
Parkinson Disease
Orthostatic Hypotension
Eligibility:
All Genders
18-75 years
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: compar...
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 ob...
Eligibility Criteria
Inclusion
- Phase 1:
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT07139756
Start Date
October 1 2025
End Date
March 31 2028
Last Update
August 24 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011