NCT03096743

Evaluating Raised Intracranial Pressure Using MR Elastography

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

The goal of this study is to evaluate the brain elasticity in patients with idiopathic intracranial hypertension (IIH) and other forms of raised intracranial pressure, such as obstructive hydrocephalus. Investigators will evaluate for a correlation between brain stiffness and opening pressure on lumbar puncture. Investigators will also evaluate for changes in brain stiffness after interventions that are aimed at lowering intracranial pressure, including lumbar punctures, medications, and surgical interventions, such as ventriculoperitoneal shunts. Lastly, investigators will compare MR elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on MRI.

Conditions

• Idiopathic Intracranial Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-10
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2017-03-30
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study