Evaluating Raised Intracranial Pressure Using MR Elastography

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).

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Intracranial Hypertension
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John J. Chen, M.D., Ph.D.; Phone Number: 507-284-7140; Email: chen.john@mayo.edu
• Study Contact Backup: Name: Jacqueline A. Leavitt, M.D.; Phone Number: 507-284-6263; Email: leavitt.jacqueline@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Jessica Morgan; Phone Number: 507-293-9689; Email: nolte.jessica@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.; Diagnostic test: MRI structural brain imaging; MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.; Procedure: 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.; Diagnostic test: 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.; Diagnostic test: Optic nerve B-scan ultrasound; Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
Experimental: 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.	Diagnostic test: 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.; Diagnostic test: MRI structural brain imaging; MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.; Diagnostic test: 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.; Diagnostic test: Optic nerve B-scan ultrasound; Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-2 weeks prior to lumbar puncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	1--2 weeks prior to lumbar puncture

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: John J Chen, M.D., Ph.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: 16-007037; 5U10EY025990-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes