Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03212976

Acronym

MR-ICP

Enrollment

Registered

2017-07-11

Start date

2017-10-26

Completion date

2020-10-15

Last updated

2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hypertension, Intracranial Pathology

Keywords

Non-Invasive, Magnetic Resonance Imaging, Ventricular catheters

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.

Interventions

PROCEDUREPhase contrast magnetic resonance imaging

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026