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Evaluating Raised Intracranial Pressure Using MR Elastography

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR elastography
MRI structural brain imaging
Lumbar puncture
Optical Coherence Tomography (OCT) imaging
Optic nerve B-scan ultrasound
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Intracranial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with increased intracranial hypertension

Patient without raised intracranial hypertension

Arm Description

Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
December 15, 2016
Last Updated
May 24, 2023
Sponsor
Mayo Clinic
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT03096743
Brief Title
Evaluating Raised Intracranial Pressure Using MR Elastography
Official Title
Evaluating Raised Intracranial Pressure Using MR Elastography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with increased intracranial hypertension
Arm Type
Experimental
Arm Description
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
Arm Title
Patient without raised intracranial hypertension
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MR elastography
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI structural brain imaging
Intervention Description
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
Intervention Type
Procedure
Intervention Name(s)
Lumbar puncture
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical Coherence Tomography (OCT) imaging
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Optic nerve B-scan ultrasound
Intervention Description
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
Primary Outcome Measure Information:
Title
MR elastography measurement of the brain elasticity
Description
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
Time Frame
1-2 weeks prior to lumbar puncture
Secondary Outcome Measure Information:
Title
MRI finding
Description
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.
Time Frame
1--2 weeks prior to lumbar puncture
Title
Ocular Coherence Tomography (OCT) finding
Description
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
Time Frame
1--2 weeks prior to lumbar puncture
Title
Optic Nerve B-scan ultrasound finding
Description
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.
Time Frame
1--2 weeks prior to lumbar puncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John J. Chen, M.D., Ph.D.
Phone
507-284-7140
Email
chen.john@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline A. Leavitt, M.D.
Phone
507-284-6263
Email
leavitt.jacqueline@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Chen, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Morgan
Phone
507-293-9689
Email
nolte.jessica@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Evaluating Raised Intracranial Pressure Using MR Elastography

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