Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure (MR-ICP)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Intracranial Hypertension; Intracranial Pathology
• Intervention / Treatment: Procedure: Phase contrast magnetic resonance imaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashish Shah, MD; Phone Number: 305-243-6946; Email: ashish.shah@jhsmiami.org

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Jackson Memorial Hospital
      • Contact: Ashish Shah, MD; Phone Number: 305-243-6946; Email: ashish.shah@jhsmiami.org
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Hospital
      • Contact: Ashish Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Phase 1; Patients with an intracranial pressure monitor will undergo phase contrast magnetic resonance imaging to measure their ICP.	Procedure: Phase contrast magnetic resonance imaging; Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure
Other: Study Phase 2; 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; Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Ronald Benveniste, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Non-Invasive; Ventricular catheters
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension
• Other Study ID Numbers: 20170130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No