Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

Study Overview
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Brief Summary
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This study is designed to evaluate the accuracy of a non-invasive method phase-contrast magnetic resonance imaging (MR-ICP) for assessing intracranial pressure (Phase 1). To perform second phase contrast imaging to evaluate the patency and flow of ventricular catheters after MR-ICP imaging (Phase 2).

Detailed Description
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The study will be divided into 2 phases. In Phase 1, patients with an intracranial pressure monitor will be recruited to the study, while in Phase 2, patients with shunts or Cerebral Spinal Fluid (CSF) access devices (Ommaya, reservoir, etc.) will be eligible for the study. Two separate groups of patients will be recruited to each phase of the study. Each phase of the study will involve MR-ICPs. The MR-ICP is an extra 5-10 minute sequence at the end of a MRI that assesses the pressure in the head. The MRI will take scans of the brain during different phases of the cardiac cycle and will assess the volume changes while the patient is lying flat. The pressure in the head will be estimated based on these calculations. This estimate will be compared to the pressure in the head as determined by the ICP monitor.

Official Title
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Assessment of the Clinical Efficacy of a Non-Invasive Measurement of Intracranial Pressure by Magnetic Resonance Phase Contrast Imaging

Conditions
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Intracranial Pathology, Intracranial Hypertension

Intervention / Treatment
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* Procedure: Phase contrast magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for a MRI by Attendings in the Department of Neurological Surgery at the University of Miam with intracranial pathology with external ventricular drains (EVDs) or intracranial bolts placed for hydrocephalus or intracranial hypertension. Bolts must be placed prior to enrollment in the study to avoid any alterations in standard procedure All pathological entities that produce intracranial hypertension will be included (trauma, tumor, vascular, infectious, inflammatory, etc). Patients must undergo a MRI for another clinically indicated reason (diagnosis, surveillance, cervical MRI clearance, prognosis, etc). English and Spanish-speaking patients Exclusion Criteria: Unable to obtain MRI due to prior implants, metallic material, inability to sit still Refractory intracranial hypertension (not controlled with medications, surgery, or EVD) Unable to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Phase 1<br>Patients with an intracranial pressure monitor will undergo phase contrast magnetic resonance imaging to measure their ICP. | Procedure: Phase contrast magnetic resonance imaging<br>* Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure<br>|
| Other: Study Phase 2<br>Patients with shunts or CSF access devices such as Ommaya reservoir, etc will undergo phase contrast magnetic resonance imaging | Procedure: Phase contrast magnetic resonance imaging<br>* Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial Pressure Measurement | Ratio of intracranial volume | 1 day | 
| Patency of ventricular catheters | Patency of ventricular catheters will be measured using multi-voxel MRI-ICP to qualitatively assess presence of CSF flow. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Invasive, Magnetic Resonance Imaging, Ventricular catheters