Evaluating Raised Intracranial Pressure Using MR Elastography
NCT ID: NCT03096743
Last Updated: 2025-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2017-01-10
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
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.
MRI structural brain imaging
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
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.
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.
Optic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
Patient without raised intracranial hypertension
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.
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.
MRI structural brain imaging
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
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.
Optic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
Interventions
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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.
MRI structural brain imaging
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
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.
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.
Optic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
Eligibility Criteria
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Inclusion Criteria
* Group 2: Patients without raised intracranial pressure.
Exclusion Criteria
* Pregnancy (self-reported)
* Individuals for whom MR is contraindicated
18 Years
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
Mayo Clinic
OTHER
Responsible Party
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John J Chen
Principal Investigator
Principal Investigators
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John J Chen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica Morgan
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-007037
Identifier Type: -
Identifier Source: org_study_id