NCT03212976

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intracranial Pathology
• Intracranial Hypertension

Interventions

Type	Name	Description
PROCEDURE	Phase contrast magnetic resonance imaging	Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure

Timeline

• Start date: 2017-10-26
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2017-07-11
• Last updated: 2024-12-05

Locations

2 sites across 1 country: United States