N/A
N=5
Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
Intracranial Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT03041441 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Intracranial Pressure Measurements Estimated by the MRICP Technique. — 6.5 cm H20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI algorithm (Device); Lumbar puncture (Procedure); Epidural patching (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intracranial Pressure Measurements Estimated by the MRICP Technique. |
6.5 | — |
| PRIMARY Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture |
19.0 | — |
| SECONDARY Change in Intracranial Pressure Estimated With MR Technique |
— | — |
| SECONDARY Change in Caliber to the Transverse Venous Sinus Caliber |
1.1 | — |
| SECONDARY Change in Flow Velocity Through the Transverse Dural Venous Sinus |
— | — |
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT03041441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.