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Evaluating Raised Intracranial Pressure Using MR Elastography

NCT03096743 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-04

No results posted yet for this study

Summary

Investigators will compare magnetic resonance (MR) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on magnetic resonance imaging (MRI).

Conditions

  • Idiopathic Intracranial Hypertension

Interventions

DIAGNOSTIC_TEST

MR elastography

MR elastography image acquisition will be conducted on the Compact 3T MRI scanner using a modified single-shot spin-echo echo-planar imaging pulse sequence.

DIAGNOSTIC_TEST

MRI structural brain imaging

MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.

PROCEDURE

Lumbar puncture

All patients with papilledema will get lumbar punctures with opening pressure as part of their work-up for papilledema. A small number of patients without increased intracranial pressure will receive a lumbar puncture.

DIAGNOSTIC_TEST

Optical Coherence Tomography (OCT) imaging

Optical Coherence Tomography (OCT) imaging will measure the peripapillary retinal nerve fiber layer (RNFL) thickness measurements The images with enhanced depth imaging will be obtained to measure the Bruch's membrane orientation.

DIAGNOSTIC_TEST

Optic nerve B-scan ultrasound

Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • John J Chen, M.D., Ph.D. · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2030-12-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096743 on ClinicalTrials.gov