200 Participants Needed

MR Elastography for Intracranial Hypertension

JJ
JA
Overseen ByJacqueline A. Leavitt, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Lumbar puncture, Spinal tap, LP, MR elastography, Magnetic Resonance Elastography, MR Elastography, MRE, MRI structural brain imaging, Magnetic Resonance Imaging, MRI, Optical Coherence Tomography (OCT) imaging, Optical Coherence Tomography imaging, OCT imaging, Optic nerve B-scan ultrasound, Optic nerve B-scan ultrasound, B-scan ultrasound of the optic nerve for Intracranial Hypertension?

Research shows that Magnetic Resonance Elastography (MRE) can accurately measure brain stiffness, which is useful in conditions like elevated intracranial pressure. In a study, MRE was used to assess brain stiffness in patients with pseudotumor cerebri (a condition similar to intracranial hypertension) before and after lumbar puncture, showing its potential to provide valuable clinical information.12345

Is MR Elastography safe for use in humans?

Research shows that the vibration levels used in MR Elastography are below the safety limits set by European guidelines for whole-body vibrations, indicating it is generally safe for human use.12356

How is the treatment of MR Elastography for Intracranial Hypertension different from other treatments?

MR Elastography (MRE) is unique because it noninvasively measures brain stiffness by analyzing how shear waves move through brain tissue, which can help assess changes in brain pressure before and after a lumbar puncture (spinal tap). This approach is different from other treatments as it provides detailed mechanical insights into brain tissue without the need for invasive procedures.12378

Research Team

JJ

John J Chen, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with conditions like idiopathic intracranial hypertension or obstructive hydrocephalus, which cause increased pressure inside the skull. It's also for those without such pressure issues to serve as a comparison group. People can't join if they're under 18, pregnant, or have conditions that make MR imaging unsafe for them.

Inclusion Criteria

You do not have increased pressure inside your head.
Everyone who participates must meet the following requirements.
You have swelling of the optic nerve due to high pressure inside your head.
See 1 more

Exclusion Criteria

People who should not have an MRI.
Age <18
You are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo MR elastography, MRI, OCT imaging, and optic nerve B-scan ultrasound to establish baseline measurements

1-2 weeks
1 visit (in-person)

Intervention

Participants may receive interventions such as lumbar punctures, medications, or surgical interventions to lower intracranial pressure

Varies based on intervention

Follow-up

Participants are monitored for changes in brain stiffness and other measurements after interventions

1-2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Lumbar puncture
  • MR elastography
  • MRI structural brain imaging
  • Optical Coherence Tomography (OCT) imaging
  • Optic nerve B-scan ultrasound
Trial OverviewThe study tests how well MR elastography can measure raised intracranial pressure compared to other noninvasive methods like OCT imaging of retinal nerve fibers and MRI signs. Participants will undergo these imaging techniques along with lumbar punctures and optic nerve ultrasounds.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Patients with increased intracranial hypertensionExperimental Treatment5 Interventions
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
Group II: Patient without raised intracranial hypertensionExperimental Treatment4 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Findings from Research

Magnetic resonance elastography (MRE) demonstrated good reproducibility in measuring brain stiffness, with a correlation coefficient of r > 0.78, indicating reliable results in normal volunteers.
In patients with pseudotumor, brain stiffness was significantly higher during opening lumbar puncture compared to normal volunteers, suggesting potential diagnostic value, although no correlation was found between cerebrospinal fluid pressures and brain stiffness.
Magnetic resonance elastography to estimate brain stiffness: Measurement reproducibility and its estimate in pseudotumor cerebri patients.Kolipaka, A., Wassenaar, PA., Cha, S., et al.[2023]
Magnetic resonance elastography (MRE) has shown promise in predicting the mechanical properties of intracranial tumors, such as consistency and adhesiveness, which could inform intraoperative conditions.
Despite its potential, MRE is still in the preclinical stage, with current studies being limited by small and variable sample sizes, highlighting the need for larger cohorts and standardized techniques for future clinical application.
Magnetic Resonance Elastography in Intracranial Neoplasms: A Scoping Review.Aunan-Diop, JS., Halle, B., Pedersen, CB., et al.[2022]
The spin-echo echo-planar imaging (SE-EPI) sequence for magnetic resonance elastography (MRE) provides highly reproducible and repeatable measurements of intervertebral disc stiffness, showing excellent correlation with the standard gradient recalled echo (GRE) technique.
SE-EPI significantly reduces scan times by at least 51% compared to GRE, making it a more efficient option for assessing the mechanical properties of intervertebral discs in healthy individuals.
Magnetic Resonance Elastography of Intervertebral Discs: Spin-Echo Echo-Planar Imaging Sequence Validation.Co, M., Dong, H., Boulter, DJ., et al.[2023]

References

Magnetic resonance elastography to estimate brain stiffness: Measurement reproducibility and its estimate in pseudotumor cerebri patients. [2023]
Magnetic Resonance Elastography in Intracranial Neoplasms: A Scoping Review. [2022]
Magnetic Resonance Elastography of Intervertebral Discs: Spin-Echo Echo-Planar Imaging Sequence Validation. [2023]
[Magnetic resonance elastography of the brain]. [2021]
Harnessing brain waves: a review of brain magnetic resonance elastography for clinicians and scientists entering the field. [2021]
Vibration safety limits for magnetic resonance elastography. [2021]
Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. [2018]
Exploration of highly accelerated magnetic resonance elastography using high-density array coils. [2020]