Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure
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
🗓️ Study Start (Actual) 26 October 2017
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 June 2017
  • First Submitted that Met QC Criteria 6 July 2017
  • First Posted 11 July 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 September 2023
  • Last Update Posted 14 September 2023
  • Last Verified September 2023