Ireland
--:--IST
Recruiting Observational

Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

NCT04668261 · tracked via the Priya Life Science Switzerland tracker
Phase
Observational
Started
2021-01-01
Last updated
2020-12-29

Condition(s) studied

Brain Blood Flow Impairment

Investigational drug(s) / intervention(s)

Advanced imaging investigation

Advanced imaging investigation: MRI imaging

Study summary

Primary study objective:

• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.

Secondary study objectives:

* Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.
* Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.
* Determining hemodynamic imaging patterns that can be tested as novel imaging markers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion criteria Patients: * Male and Female subjects \>18 years of age * Written informed consent after participants' information. Foreign speaking patients should be accompanied by a person with sufficient German language proficiency to act as a translator * Neurosurgical diseases with the potential to alter blood flow to the brain: * Cerebrovascular disease * Brain tumors * Normal Pressure Hydrocephalus Healthy subjects: * Male and Female subjects \>18 years of age * Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator Exclusion criteria: Patients: * Unwilling or unable to co-operate with breathing maneuvers * Respiratory or cardiac limitations to breathing through a mask * Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis) * Standard contraindications for MRI scanning * Verbal confirmed pregnancy * Known multiple intracranial diseases * Presence of intracranial hemorrhage within the last 3 months * Symptomatic increased intracranial pressure Healthy subjects: * Unwilling or unable to co-operate with breathing maneuvers * Respiratory or cardiac limitations to breathing through a mask * Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis) * Standard contraindications for MRI scanning * Verbal confirmed pregnancy * Anamnesticly a history of neurological disease or current neurological deficits.

Primary outcome measure(s)

  • • Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort. — 5 years
    blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements

Trial sites (1)

FacilityCityRegionStatus
University Hospital Zurich Zurich Switzerland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04668261 on ClinicalTrials.gov ↗ ← All trials in Switzerland