An interventional study of MR elastography and MRI structural brain imaging in Idiopathic Intracranial Hypertension, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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).
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.
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This study's planned enrollment of 200 is above the median of 60 across 36 interventional studies indexed under Pseudotumor Cerebri.
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All subjects will have the following inclusion criteria:
All subjects will have the following exclusion criteria:
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
Diagnostic Test: MR elastography · Diagnostic Test: MRI structural brain imaging · Procedure: Lumbar puncture · Diagnostic Test: Optical Coherence Tomography (OCT) imaging · Diagnostic Test: Optic nerve B-scan ultrasound
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.
Diagnostic Test: MR elastography · Diagnostic Test: MRI structural brain imaging · Diagnostic Test: Optical Coherence Tomography (OCT) imaging · Diagnostic Test: Optic nerve B-scan ultrasound
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.
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
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.
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.
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
MR elastography measurement of the brain elasticity
The primary outcome measure is the difference in the brain elasticity on MR elastography between patients with raised intracranial pressure and those with normal intracranial pressure
Time frame: 1-2 weeks prior to lumbar puncture
MRI finding
The secondary outcome measurement are the retinal nerve fiber layer (RNFL) thickness and Bruch's membrane configuration on the MRI findings of raised intracranial pressure (optic nerve sheath diameter and pituitary/sella ratio). The cutoff from abnormal-to-normal will be established. The sensitivity and specificities will be established and compared against the other secondary outcome measurements and against MR elastography.
Time frame: 1--2 weeks prior to lumbar puncture
Ocular Coherence Tomography (OCT) finding
The secondary outcome measurements are the retinal nerve fiber layer (RNFL) thickness and Bruch's membrane configuration using ocular coherence tomography (OCT) of raised intracranial pressure (optic nerve sheath diameter and pituitary/sella ratio). The cutoff from abnormal-to-normal will be established. The sensitivity and specificities will be established and compared against the other secondary outcome measurements and against MR elastography
Time frame: 1--2 weeks prior to lumbar puncture
Optic Nerve B-scan ultrasound finding
The secondary outcome measurement are the retinal nerve fiber layer (RNFL) thickness and Bruch's membrane configuration on the optic nerve B-scan ultrasound findings of raised intracranial pressure (optic nerve sheath diameter and pituitary/sella ratio). The cutoff from abnormal-to-normal will be established. The sensitivity and specificities will be established and compared against the other secondary outcome measurements and against MR elastography.
Time frame: 1--2 weeks prior to lumbar puncture
Plan to share: No
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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