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Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension

NCT03041441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-07-28

Study results available
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Summary

The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment of this condition.

Conditions

  • Intracranial Hypotension

Interventions

DEVICE

MRI algorithm

MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion

PROCEDURE

Lumbar puncture

Lumbar puncture according to the standard-of-care treatment plan.

PROCEDURE

Epidural patching

Epidural patching will be performed to the standard-of -care treatment plan

Sponsors & Collaborators

Principal Investigators

  • Peter Kranz, MD · Duke University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2019-10-25
Completion
2019-10-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041441 on ClinicalTrials.gov