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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212976
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : October 21, 2022
Sponsor:
Information provided by (Responsible Party):
Ronald Benveniste, University of Miami

Brief 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).


Condition or disease Intervention/treatment Phase
Intracranial Pathology Intracranial Hypertension Procedure: Phase contrast magnetic resonance imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Clinical Efficacy of a Non-Invasive Measurement of Intracranial Pressure by Magnetic Resonance Phase Contrast Imaging
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Intracranial Pressure Measurement [ Time Frame: 1 day ]
    Ratio of intracranial volume

  2. Patency of ventricular catheters [ Time Frame: 7 days ]
    Patency of ventricular catheters will be measured using multi-voxel MRI-ICP to qualitatively assess presence of CSF flow.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212976


Contacts
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Contact: Ashish Shah, MD 305-243-6946 ashish.shah@jhsmiami.org

Locations
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United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Ashish Shah, MD    305-243-6946    ashish.shah@jhsmiami.org   
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Ashish Shah, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ronald Benveniste, MD, PhD University of Miami
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Responsible Party: Ronald Benveniste, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03212976    
Other Study ID Numbers: 20170130
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ronald Benveniste, University of Miami:
Non-Invasive
Magnetic Resonance Imaging
Ventricular catheters
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases