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

NCT07139756 | Not Yet Recruiting

• 1 other identifier: 2024-01828
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Orthostatic Hypotension

Keywords

lower body negative pressure; parkinson disease; orthostatic hypotension

Outcome Measures

Primary Outcomes (1)

• Differences and changes in BOLD fMRI signal intensity

  Changes in brain BOLD fMRI signal in the dorsolateral medulla of the brainstem in response to LBNP

  1.5 hour

Secondary Outcomes (4)

• Functional connectivity

  1.5 hour

• Structural connectivity

  30 minutes

• Contrast-enhanced renal ultrasound

  1.5 hour

• pre-cerebral blood flow

  30 minutes

Study Arms (3)

Healthy volunteers

Healthy volunteers with normal office blood pressure (\<140/90 mmHg). Lower body negative pressure during brain BOLD fMRI in 3T and 7T MRI scanner.

Diagnostic Test: Lower body negative pressure

Parkinson patients without orthostatic hypotension

Patients with clinically established Parkinson disease, treated by dopamine replacement therapy, and without orthostatic hypotension as shown by a Schellong test. Lower body negative pressure during brain BOLD fMRI, renal contrast-enhanced ultrasound

Diagnostic Test: Lower body negative pressure

Parkinson patients with orthostatic hypotension

Patients with clinically established Parkinson disease, treated by dopamine replacement therapy, and having orthostatic hypotension as shown by a Schellong test. Lower body negative pressure during brain BOLD fMRI, renal contrast-enhanced ultrasound

Diagnostic Test: Lower body negative pressure

Interventions

Lower body negative pressure DIAGNOSTIC_TEST

LBNP is a technique that redistributes blood from the upper body to the dependent regions of the legs, thus reducing central venous pressure and venous return and thereby activating the sympathetic nervous system (SNS). The subject is placed in a cylindrical airtight tank, which is sealed at the level of the iliac crests, and sub-atmospheric pressure is produced using a vacuum pump. It can be used to characterize the cardiovascular responses to orthostatic stress

Healthy volunteers; Parkinson patients with orthostatic hypotension; Parkinson patients without orthostatic hypotension

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1: population of healthy participants Phase 2: population of PD patients with or without OH

You may qualify if:

• 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

You may not qualify if:

• 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:
• Signed informed consent
• Fulfilling Movement Disorder Society clinical criteria for "clinically established PD"
• Age ≥18 years and \<75 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Simple blood count, creatinine, sodium, potassium, fasting glucose, pregnancy test for women with childbearing potential

MeSH Terms

Conditions

Parkinson Disease; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Grégoire Wuerzner

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégoire Wuerzner, Prof

CONTACT

+41 79 556 1973; Gregoire.Wuerzner@chuv.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: one year after publication of the data

Locations

CH (1)