Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostat… (NCT07139756) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension
Switzerland130 participantsStarted 2025-10-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences and changes in BOLD fMRI signal intensity