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.
12345Is 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.
12356How 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.
12378Eligibility 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.
+1 more
Exclusion Criteria
People who should not have an MRI.
Age <18
You are pregnant.
Trial 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)
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Eye Institute (NEI)Collaborator
References
Magnetic resonance elastography to estimate brain stiffness: Measurement reproducibility and its estimate in pseudotumor cerebri patients. [2023]This study determines the reproducibility of magnetic resonance elastography (MRE) derived brain stiffness in normal volunteers and compares it against pseudotumor patients before and after lumbar puncture (LP). MRE was performed on 10 normal volunteers for reproducibility and 14 pseudotumor patients before and after LP. During LP, opening and closing cerebrospinal fluid (CSF) pressures were recorded before and after removal of CSF and correlated to brain stiffness. Stiffness reproducibility was observed (r > 0.78; p
Magnetic Resonance Elastography in Intracranial Neoplasms: A Scoping Review. [2022]Magnetic resonance elastography (MRE) allows noninvasive assessment of intracranial tumor mechanics and may thus be predictive of intraoperative conditions. Variations in the use of technical terms complicate reading of current literature, and there is need of a review using consolidated nomenclature.
Magnetic Resonance Elastography of Intervertebral Discs: Spin-Echo Echo-Planar Imaging Sequence Validation. [2023]Magnetic resonance elastography (MRE) is an imaging technique that can noninvasively assess the shear properties of the intervertebral disc (IVD). Unlike the standard gradient recalled echo (GRE) MRE technique, a spin-echo echo-planar imaging (SE-EPI) sequence has the potential to improve imaging efficiency and patient compliance.
[Magnetic resonance elastography of the brain]. [2021]Magnetic resonance elastography (MRE) is a novel imaging modality allowing quantification of tissue consistency. Multiple trials have focused on the use of MRE to describe meningioma consistency prior to surgery and on improving diagnostic accuracy of normal pressure hydrocephalus and other dementias. MRE shows promising results, but still lacks direct clinical translational value. Within neurosurgery and neurosciences MRE could contribute and improve decision-making, diagnosis and treatment. Furthermore, the use of MRE will improve the basic understanding of neuroanatomy, physiology and pathology.
Harnessing brain waves: a review of brain magnetic resonance elastography for clinicians and scientists entering the field. [2021]Brain magnetic resonance elastography (MRE) is an imaging technique capable of accurately and non-invasively measuring the mechanical properties of the living human brain. Recent studies have shown that MRE has potential to provide clinically useful information in patients with intracranial tumors, demyelinating disease, neurodegenerative disease, elevated intracranial pressure, and altered functional states. The objectives of this review are: (1) to give a general overview of the types of measurements that have been obtained with brain MRE in patient populations, (2) to survey the tools currently being used to make these measurements possible, and (3) to highlight brain MRE-based quantitative biomarkers that have the highest potential of being adopted into clinical use within the next 5 to 10 years. The specifics of MRE methodology strategies are described, from wave generation to material parameter estimations. The potential clinical role of MRE for characterizing and planning surgical resection of intracranial tumors and assessing diffuse changes in brain stiffness resulting from diffuse neurological diseases and altered intracranial pressure are described. In addition, the emerging technique of functional MRE, the role of artificial intelligence in MRE, and promising applications of MRE in general neuroscience research are presented.
Vibration safety limits for magnetic resonance elastography. [2021]Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within a tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit, and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans.
Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. [2018]Magnetic resonance elastography (MRE) analyzes shear wave movement through tissue to determine stiffness. In a prior study, measurements with first-generation brain MRE techniques correlated with intraoperative observations of overall meningioma stiffness.
Exploration of highly accelerated magnetic resonance elastography using high-density array coils. [2020]Magnetic resonance elastography (MRE) measures tissue mechanical properties by applying a shear wave and capturing its propagation using magnetic resonance imaging (MRI). By using high density array coils, MRE images are acquired using single echo acquisition (SEA) and at high resolutions with significantly reduced scan times.