Health TrialsbyHealthPanel

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

ConditionsParkinson DiseaseOrthostatic Hypotension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: Healthy volunteers1 intervention
Group B: Parkinson patients without orthostatic hypotension1 intervention
Group C: Parkinson patients with orthostatic hypotension1 intervention

Trial outcomes

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

Time frame
1.5 hour

Secondary outcomes

1

Functional connectivity

Activation patterns in spatially separated brain regions tending to have synchronous activity in resting state and activation pattern change during LBNP

Time frame
1.5 hour
2

Structural connectivity

Map of anatomical (neural) connections within the brain in PD patients with and without OH

Time frame
30 minutes
3

Contrast-enhanced renal ultrasound

Changes in renal perfusion in response to LBNP

Time frame
1.5 hour
4

pre-cerebral blood flow

changes in pre-cerebral blood flow in response to LBNP

Time frame
30 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire Vaudois

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Collaborator

University Hospital, Geneva

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: