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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03096743
Other study ID # 16-007037
Secondary ID 5U10EY025990-02
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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