Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Conditions
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Brain Blood Flow Impairment

Intervention / Treatment
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* Other: Advanced imaging investigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurosurgical patients<br>• Neurosurgical diseases with the potential to alter blood flow to the brain: Cerebrovascular disease Brain tumors Normal Pressure Hydrocephalus | Other: Advanced imaging investigation<br>* MRI imaging<br>|
| Healthy subjects<br>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 | Other: Advanced imaging investigation<br>* MRI imaging<br>|

What is the study measuring?
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Primary Outcome Measures

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