Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

Conditions:High Blood Pressure (Hypertension), Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Age Range:18 - 99
Start Date:October 26, 2017
End Date:December 2021
Contact:Ashish Shah, MD

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Assessment of the Clinical Efficacy of a Non-Invasive Measurement of Intracranial Pressure by Magnetic Resonance Phase Contrast Imaging

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).

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.

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

- Unable to obtain informed consent
We found this trial at
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
Miami, FL
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Phone: 305-243-6946
Miami, FL
Click here to add this to my saved trials