Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Advanced imaging investigation.
- Who it may be relevant to
- Registry conditions: Brain Blood Flow Impairment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Primary study objective:
• 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.
Interventions
- Other Advanced imaging investigation
MRI imaging
Primary outcome measures
- • Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort. [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Hospital Zurich — Zurich
Identifiers
NCT: NCT04668261 · 2020-02314