Clinical trial NCT03212976: Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure
Official title: Assessment of the Clinical Efficacy of a Non-Invasive Measurement of Intracranial Pressure by Magnetic Resonance Phase Contrast Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracranial Pathology
Intracranial Hypertension
Keywords: Non-Invasive
Magnetic Resonance Imaging
Ventricular catheters
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Pressure Measurement
timeFrame: 1 day
measure: Patency of ventricular catheters
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Ronald Benveniste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: