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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 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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,741 Total Patients Enrolled
National Eye Institute (NEI)NIH
558 Previous Clinical Trials
1,408,271 Total Patients Enrolled
John J Chen, M.D., Ph.D.Principal InvestigatorMayo Clinic

Media Library

Lumbar puncture (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03096743 — N/A
Pseudotumor cerebri Research Study Groups: Patients with increased intracranial hypertension, Patient without raised intracranial hypertension
Pseudotumor cerebri Clinical Trial 2023: Lumbar puncture Highlights & Side Effects. Trial Name: NCT03096743 — N/A
Lumbar puncture (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03096743 — N/A
~21 spots leftby Dec 2025
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