Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

Intracranial Hypertension Clinical Trial

— MR-ICP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03212976
• Other study ID #: 20170130
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Ashish Shah, MD
• Phone: 305-243-6946
• Email: ashish.shah[@]jhsmiami.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pathology

Intervention

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

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Pressure Measurement	Ratio of intracranial volume	1 day
Primary	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