MedDataX Logo

Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

NCT ID: NCT03212976

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-26

Study Completion Date

2020-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Pathology Intracranial Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Non-Invasive Magnetic Resonance Imaging Ventricular catheters

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Phase 1

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

Group Type OTHER

Phase contrast magnetic resonance imaging

Intervention Type PROCEDURE

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

Group Type OTHER

Phase contrast magnetic resonance imaging

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phase contrast magnetic resonance imaging

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Miami

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ronald Benveniste

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronald Benveniste, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

University of Miami Hospital

Miami, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20170130

Identifier Type: -

Identifier Source: org_study_id