Idiopathic Intracranial HypertensionNCT03096743
Evaluating Raised Intracranial Pressure Using MR Elastography
A study testing MR elastography, MRI structural brain imaging and Lumbar puncture in people with Idiopathic Intracranial Hypertension, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- MR elastography, MRI structural brain imaging and Lumbar puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2017to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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).
Read the 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
- Being tested
- MR elastography, MRI structural brain imaging, Lumbar puncture, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR elastographyDiagnostic test
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 imagingDiagnostic test
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
Lumbar punctureProcedure or surgery
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) imagingDiagnostic test
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 ultrasoundDiagnostic test
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
| Study group | Role | What they receive |
|---|---|---|
| Patients with increased intracranial hypertension | Experimental | Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture. Receives: 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 |
| Patient without raised intracranial hypertension | Experimental | 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. Receives: Diagnostic Test: MR elastography; Diagnostic Test: MRI structural brain imaging; Diagnostic Test: Optical Coherence Tomography (OCT) imaging; Diagnostic Test: Optic nerve B-scan ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 weeks prior to lumbar puncture
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: 1--2 weeks prior to lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start10 Jan 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, John J Chen, Mayo Clinic
- Investigators
- John J Chen, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096743
- Sponsor's protocol ID
- 16-007037
- Other IDs
- 5U10EY025990-02
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2016
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Raised Intracranial Pressure Using MR Elastography
- ClinicalTrials.gov ID
- NCT03096743
- Acronym / sponsor ID
- 16-007037
- Conditions
- Idiopathic Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with increased intracranial hypertension | Experimental | 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 ultrasoundPatients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture. |
| Patient without raised intracranial hypertension | Experimental | Diagnostic Test: MR elastography, Diagnostic Test: MRI structural brain imaging, Diagnostic Test: Optical Coherence Tomography (OCT) imaging, Diagnostic Test: Optic nerve B-scan ultrasoundPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR elastographyMR 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 | Patient without raised intracranial hypertension, Patients with increased intracranial hypertension |
| MRI structural brain imagingMRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography. | Diagnostic test | Patient without raised intracranial hypertension, Patients with increased intracranial hypertension |
| Lumbar punctureAll 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. | Procedure or surgery | Patients with increased intracranial hypertension |
| Optical Coherence Tomography (OCT) imagingOptical 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 | Patient without raised intracranial hypertension, Patients with increased intracranial hypertension |
| Optic nerve B-scan ultrasoundUltrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface. | Diagnostic test | Patient without raised intracranial hypertension, Patients with increased intracranial hypertension |
Primary outcome
MR elastography measurement of the brain elasticity
Time frame: 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
3 secondary outcomes
MRI finding
Time frame: 1--2 weeks prior to lumbar puncture
Ocular Coherence Tomography (OCT) finding
Time frame: 1--2 weeks prior to lumbar puncture
Optic Nerve B-scan ultrasound finding
Time frame: 1--2 weeks prior to lumbar puncture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Chen, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR elastography, MRI structural brain imaging and Lumbar puncture in people with Idiopathic Intracranial Hypertension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR elastography measurement of the brain elasticity (time frame: 1-2 weeks prior to lumbar puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.