Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

NCT03212976 | Terminated

• 1 other identifier: 20170130
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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).

Conditions

Intracranial Pathology; Intracranial Hypertension

Keywords

Non-Invasive; Magnetic Resonance Imaging; Ventricular catheters

Outcome Measures

Primary Outcomes (2)

• Intracranial Pressure Measurement

  Ratio of intracranial volume

  1 day

• 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

Study Arms (2)

Study Phase 1

OTHER

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

Procedure: Phase contrast magnetic resonance imaging

Study Phase 2

OTHER

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

Interventions

Phase contrast magnetic resonance imaging PROCEDURE

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

Study Phase 1; Study Phase 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ronald Benveniste, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 11, 2017
• Study Start: October 26, 2017
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)