Evaluating Raised Intracranial Pressure Using MR Elastography

Idiopathic Intracranial Hypertension Clinical Trial

Official title:

Evaluating Raised Intracranial Pressure Using MR Elastography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096743
• Other study ID #: 16-007037
• Secondary ID: 5U10EY025990-02
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: John J. Chen, M.D., Ph.D.
• Phone: 507-284-7140
• Email: chen.john[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 magnetic resonance imaging (MRI).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

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.
• 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.
• Optic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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