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Набор скоро начнётся NCT07139756

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

— Наблюдательное Parkinson Disease Orthostatic Hypotension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lower body negative pressure.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Orthostatic Hypotension. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
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Официальное название

Deciphering the Mechanisms of Central Blood Pressure Regulation in Patients With Parkinson Disease Associated With Orthostatic Hypotension: A 2-phase Observational Study With Healthy Participants and Patients With Parkinson's Disease

Обзор

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

Подробное описание

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 objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI

Phase 2 secondary objectives:

* assess modulation of functional connectivity in response to LBNP (effective connectivity analysis by psycho-physiological interactions (PPI)) and determine differences between the two groups * assess functional connectivity in resting state and determine differences between the two groups * compare structural connectivity in both groups using tractography * compare renal response to LBNP in both groups using contrast-enhanced ultrasound * compare pre-cerebral flow response to LBNP in both groups

Вмешательства

  • Диагностический тест Lower body negative pressure
    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

Первичные конечные точки

  • Differences and changes in BOLD fMRI signal intensity [Срок оценки: 1.5 hour]
Вторичные конечные точки (4)
  • Functional connectivity [Срок оценки: 1.5 hour]
  • Structural connectivity [Срок оценки: 30 minutes]
  • Contrast-enhanced renal ultrasound [Срок оценки: 1.5 hour]
  • pre-cerebral blood flow [Срок оценки: 30 minutes]

Критерии участия

Phase 1:

Критерии включения

  • 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

Критерии исключения

  • 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:

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швейцария · 1 центр
  • Centre Hospitalier Universitaire Vaudois — Lausanne

Идентификаторы

NCT: NCT07139756 · 2024-01828

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗