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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
MR-ICP Trial 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.Check my eligibility
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.See study design
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.
MR-ICP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial Pressure Measurement
Patency of ventricular catheters
MR-ICP 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
902 Previous Clinical Trials
409,986 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have an MRI due to implants or difficulty staying still.I have a condition causing increased pressure inside my skull.My high brain pressure is not controlled by medication, surgery, or external ventricular drainage.I speak English or Spanish.I am scheduled for an MRI for a health issue other than the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Study Phase 1
- Group 2: Study Phase 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a patient is over the age of 35, will they be able to participate in this research project?
"This trial is meant for patients who are between 18-99 years old. If you are above or below that age, there are 3 and 15 other trials respectively that you may be eligible for."
Answered by AI
Are we still able to accept people into the program?
"Yes, this study is looking for participants right now. The clinicaltrials.gov website says that the trial was first posted on October 26th, 2017 and updated as recently as October 20th, 2020."
Answered by AI
Are there any ineligibility requirements for this research?
"Eligible participants for this research should be aged between 18 and 99 and have a diagnosis of intracranial hypertension. Researchers are looking to enroll around 30 individuals."
Answered by AI
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