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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/22/2018
Start Date:September 14, 2017
End Date:December 31, 2019
Contact:Peter Kranz, MD
Email:peter.kranz@duke.edu
Phone:919-684-7218

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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.


Inclusion Criteria:

- Known diagnosis of intracranial hypotension, established by the following criteria:
the presence of orthostatic headache, and one or more of the following criteria: prior
CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior
spine imaging, or cranial MRI changes of intracranial hypotension.15

- Ability to provide informed consent.

- Expected ability to complete standard-of-care procedures (lumbar puncture and epidural
patching)

Exclusion Criteria:

- Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.)

- Severe claustrophobia or other condition requiring the need for anxiolysis, sedation,
or any other medication for MRI scanning

- Inability or expected inability to complete study interventions as scheduled

- Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic
reaction to required medication, lack of vascular access, etc.)
We found this trial at
1
site
Durham, North Carolina 27710
(919) 684-8111
Phone: 919-684-7218
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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