Evaluating Raised Intracranial Pressure Using MR Elastography

NCT03096743 | Active Not Recruiting FDA Device

• 2 other identifiers: 16-0070375U10EY025990-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 magnetic resonance imaging (MRI).

Conditions

Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• MRI finding

  1--2 weeks prior to lumbar puncture

• Ocular Coherence Tomography (OCT) finding

  1--2 weeks prior to lumbar puncture

• Optic Nerve B-scan ultrasound finding

  1--2 weeks prior to lumbar puncture

Study Arms (2)

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.

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.

Diagnostic Test: MR elastography; Diagnostic Test: MRI structural brain imaging; Diagnostic Test: Optical Coherence Tomography (OCT) imaging; Diagnostic Test: Optic nerve B-scan ultrasound

Interventions

MR elastography DIAGNOSTIC_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.

Patient without raised intracranial hypertension; Patients with increased intracranial hypertension

MRI structural brain imaging DIAGNOSTIC_TEST

MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.

Patient without raised intracranial hypertension; Patients with increased intracranial hypertension

Lumbar puncture PROCEDURE

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.

Patients with increased intracranial hypertension

Optical Coherence Tomography (OCT) imaging DIAGNOSTIC_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.

Patient without raised intracranial hypertension; Patients with increased intracranial hypertension

Optic nerve B-scan ultrasound DIAGNOSTIC_TEST

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 with increased intracranial hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1: Papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus
• Group 2: Patients without raised intracranial pressure.

You may not qualify if:

• Age \<18
• Pregnancy (self-reported)
• Individuals for whom MR is contraindicated

Sponsors & Collaborators

• Mayo Clinic: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Spinal Puncture; Tomography, Optical Coherence; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Tomography, Optical; Optical Imaging; Tomography

Study Officials

• John J Chen, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: March 30, 2017
• Study Start: January 10, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)