Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
NCT ID: NCT04668261
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2021-01-01
2027-11-01
Brief Summary
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• 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.
Detailed Description
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• to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.
Secondary study objectives:
* To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.
* To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.
4.2 Outcomes
Outcomes of the project:
Primary endpoint:
To find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.
Secondary endpoints:
* Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)
* Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Neurosurgical patients
• Neurosurgical diseases with the potential to alter blood flow to the brain:
* Cerebrovascular disease
* Brain tumors
* Normal Pressure Hydrocephalus
Advanced imaging investigation
MRI imaging
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
Advanced imaging investigation
MRI imaging
Interventions
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Advanced imaging investigation
MRI imaging
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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2020-02314
Identifier Type: -
Identifier Source: org_study_id