Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

University of Miami11 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Intracranial Pathology Intracranial Hypertension

Interventions

Phase contrast magnetic resonance imagingPROCEDURE

Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Jackson Memorial Hospital

Miami, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Outcomes

Primary Outcomes

Intracranial Pressure Measurement

Ratio of intracranial volume

Time frame: 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.

Time frame: 7 days

Data from ClinicalTrials.gov

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