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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MR elastography measurement of the brain elasticity
Secondary outcome measures
MRI finding
Ocular Coherence Tomography (OCT) finding
Radionuclide Imaging

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
3,208 Previous Clinical Trials
3,766,850 Total Patients Enrolled
1 Trials studying Pseudotumor Cerebri
60 Patients Enrolled for Pseudotumor Cerebri
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,728 Total Patients Enrolled
2 Trials studying Pseudotumor Cerebri
172 Patients Enrolled for Pseudotumor Cerebri
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for enrollees in this clinical experiment?

"Affirmative. It is evident on clinicaltrials.gov that this research effort, which was first established on October 1st 2017, is still ongoing and actively recruiting 200 test subjects across a single medical site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating Raised Intracranial Pressure Using MR Elastography
John J Chen 2017. "Evaluating Raised Intracranial Pressure Using MR Elastography". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03096743.
All > Idiopathic Intracranial Hypertension
~36 spots leftby Dec 2025
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