Clinical trial NCT03041441: Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
Official title: Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Hypotension
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2017-02-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is listed in Appendix 1. All research scans are performed without intravenous contrast. Approximate scan time per session will be 20-22 minutes.

Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan. Estimated values of CSF pressure derived from MRI will be compared to values measured during lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat research MRI after epidural patching will be performed to assess for differences in pre- and post-treatment scans.

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.)

Primary outcomes:
measure: Intracranial Pressure Measurements Estimated by the MRICP Technique.
timeFrame: During scan, approximately 30 minutes
measure: Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture
timeFrame: During lumbar procedure, up to 2 hours
Secondary outcomes:
measure: Change in Intracranial Pressure Estimated With MR Technique
timeFrame: Baseline, 24 hours
measure: Change in Caliber to the Transverse Venous Sinus Caliber
timeFrame: Baseline, 24 hours
measure: Change in Flow Velocity Through the Transverse Dural Venous Sinus
timeFrame: Baseline, 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Peter Kranz, MD
role: PRINCIPAL_INVESTIGATOR
References: