Evaluating Raised Intracranial Pressure Using MR Elastography

Mayo Clinic

Status: Enrolling

Conditions: Idiopathic Intracranial Hypertension

Treatments: Procedure: Lumbar puncture; Diagnostic Test: MRI structural brain imaging; Diagnostic Test: Optic nerve B-scan ultrasound; Diagnostic Test: MR elastography; Diagnostic Test: Optical Coherence Tomography (OCT) imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03096743

5U10EY025990-02 (U.S. NIH Grant/Contract)

16-007037

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

All subjects will have the following inclusion criteria:

• Group 1: Papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus
• Group 2: Patients without raised intracranial pressure.

All subjects will have the following exclusion criteria:

• Age <18
• Pregnancy (self-reported)
• Individuals for whom MR is contraindicated

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Patients with increased intracranial hypertension

Experimental group

Description:

Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.

Treatment:

Diagnostic Test: Optical Coherence Tomography (OCT) imaging

Diagnostic Test: MR elastography

Diagnostic Test: Optic nerve B-scan ultrasound

Procedure: Lumbar puncture

Diagnostic Test: MRI structural brain imaging

Patient without raised intracranial hypertension

Experimental group

Description:

Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.

Treatment:

Diagnostic Test: Optical Coherence Tomography (OCT) imaging

Diagnostic Test: MR elastography

Diagnostic Test: Optic nerve B-scan ultrasound

Diagnostic Test: MRI structural brain imaging