Idiopathic Intracranial Hypertension
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTMR 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_TESTMRI structural brain imaging
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
PROCEDURELumbar 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_TESTOptical 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_TESTOptic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
Sponsors
Mayo Clinic
National Eye Institute (NEI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MR elastography measurement of the brain elasticity | 1-2 weeks prior to lumbar puncture | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI finding | 1--2 weeks prior to lumbar puncture | 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. |
| Ocular Coherence Tomography (OCT) finding | 1--2 weeks prior to lumbar puncture | 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 |
| Optic Nerve B-scan ultrasound finding | 1--2 weeks prior to lumbar puncture | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn J Chen, M.D., Ph.D.
Mayo Clinic
Outcome results
None listed