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Diagnostic Test

Non-Invasive Intracranial Pressure Measurement for Intracranial Hypertension (MR-ICP Trial)

N/A
Recruiting
Led By Ronald Benveniste, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Unable to obtain MRI due to prior implants, metallic material, inability to sit still
Refractory intracranial hypertension (not controlled with medications, surgery, or EVD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a non-invasive MRI scan can be used to measure intracranial pressure, and whether it can be used to check the patency of ventricular catheters.

Who is the study for?
This trial is for patients with intracranial hypertension or other brain conditions who already have external ventricular drains (EVDs) or bolts in place. They must be referred for an MRI by neurosurgeons at the University of Miami and can speak English or Spanish. Those with implants that prevent MRI, uncontrolled intracranial pressure, or unable to consent are excluded.
What is being tested?
The study tests a non-invasive method using phase-contrast magnetic resonance imaging (MR-ICP) to measure intracranial pressure accurately. It also assesses the functionality of ventricular catheters post-MR-ICP imaging.
What are the potential side effects?
Since this trial involves MR imaging, there are no direct medication side effects; however, potential risks include discomfort from lying still during the scan and reactions if contrast agents are used.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have an MRI due to implants or difficulty staying still.
Select...
My high brain pressure is not controlled by medication, surgery, or external ventricular drainage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intracranial Pressure Measurement
Patency of ventricular catheters

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Study Phase 2Experimental Treatment1 Intervention
Patients with shunts or CSF access devices such as Ommaya reservoir, etc will undergo phase contrast magnetic resonance imaging
Group II: Study Phase 1Experimental Treatment1 Intervention
Patients with an intracranial pressure monitor will undergo phase contrast magnetic resonance imaging to measure their ICP.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,427 Total Patients Enrolled
Ronald Benveniste, MD, PhDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
Washington University School Of Medicine (Medical School)
Mt Sinai School Of Medicine (Residency)
2 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Phase Contrast Magnetic Resonance Imaging (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03212976 — N/A
Intracranial Hypertension Research Study Groups: Study Phase 1, Study Phase 2
Intracranial Hypertension Clinical Trial 2023: Phase Contrast Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT03212976 — N/A
Phase Contrast Magnetic Resonance Imaging (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03212976 — N/A
~0 spots leftby Dec 2024
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