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

Primary Purpose

Intracranial Pathology, Intracranial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phase contrast magnetic resonance imaging
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Pathology focused on measuring Non-Invasive, Magnetic Resonance Imaging, Ventricular catheters

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jackson Memorial HospitalRecruiting
  • University of Miami HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Study Phase 1

Study Phase 2

Arm Description

Patients with an intracranial pressure monitor will undergo phase contrast magnetic resonance imaging to measure their ICP.

Patients with shunts or CSF access devices such as Ommaya reservoir, etc will undergo phase contrast magnetic resonance imaging

Outcomes

Primary Outcome Measures

Intracranial Pressure Measurement
Ratio of intracranial volume
Patency of ventricular catheters
Patency of ventricular catheters will be measured using multi-voxel MRI-ICP to qualitatively assess presence of CSF flow.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2017
Last Updated
September 13, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03212976
Brief Title
Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure
Acronym
MR-ICP
Official Title
Assessment of the Clinical Efficacy of a Non-Invasive Measurement of Intracranial Pressure by Magnetic Resonance Phase Contrast Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pathology, Intracranial Hypertension
Keywords
Non-Invasive, Magnetic Resonance Imaging, Ventricular catheters

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Phase 1
Arm Type
Other
Arm Description
Patients with an intracranial pressure monitor will undergo phase contrast magnetic resonance imaging to measure their ICP.
Arm Title
Study Phase 2
Arm Type
Other
Arm Description
Patients with shunts or CSF access devices such as Ommaya reservoir, etc will undergo phase contrast magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
Phase contrast magnetic resonance imaging
Intervention Description
Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure
Primary Outcome Measure Information:
Title
Intracranial Pressure Measurement
Description
Ratio of intracranial volume
Time Frame
1 day
Title
Patency of ventricular catheters
Description
Patency of ventricular catheters will be measured using multi-voxel MRI-ICP to qualitatively assess presence of CSF flow.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashish Shah, MD
Phone
305-243-6946
Email
ashish.shah@jhsmiami.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Benveniste, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Shah, MD
Phone
305-243-6946
Email
ashish.shah@jhsmiami.org
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Shah, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

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