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Diagnostic Test

MR Elastography for Intracranial Hypertension

N/A

Recruiting

Led By John J Chen, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 weeks prior to lumbar puncture

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare three different methods of detecting raised intracranial pressure, including MR elastography, OCT imaging, and MRI.

Who is the study for?

This trial is for adults with conditions like idiopathic intracranial hypertension or obstructive hydrocephalus, which cause increased pressure inside the skull. It's also for those without such pressure issues to serve as a comparison group. People can't join if they're under 18, pregnant, or have conditions that make MR imaging unsafe for them.

What is being tested?

The study tests how well MR elastography can measure raised intracranial pressure compared to other noninvasive methods like OCT imaging of retinal nerve fibers and MRI signs. Participants will undergo these imaging techniques along with lumbar punctures and optic nerve ultrasounds.

What are the potential side effects?

MR elastography and MRI are generally safe but may include discomfort from lying still during scans. Lumbar puncture could cause back pain, headaches, or bleeding risks. OCT and ultrasound are low-risk but might involve minor eye discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 weeks prior to lumbar puncture

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 weeks prior to lumbar puncture

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 weeks prior to lumbar puncture for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MR elastography measurement of the brain elasticity

Secondary study objectives

MRI finding

Ocular Coherence Tomography (OCT) finding

Radionuclide Imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with increased intracranial hypertensionExperimental Treatment5 Interventions

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

Group II: Patient without raised intracranial hypertensionExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumbar puncture

2013

Completed Phase 3

~1180

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