Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
Completed · Not applicable
Conditions studied: Intracranial Hypotension
In brief
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.
Key facts
- Study ID
- NCT03041441
- Run by
- Duke University
- People needed
- 5
- Starts
- 2017-09-14
- Expected to finish
- 2019-10-26
- Last updated by the study team
- 2020-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.)
Where it is running
- Duke University — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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