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

Intracranial Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041441
• Other study ID #: Pro00078211
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: October 26, 2019

Study information

• Verified date: July 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 26, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Hypotension
• Intracranial Hypotension

Intervention

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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Pressure Measurements Estimated by the MRICP Technique.	The measurement of the momentary differences between the volumes of blood and CSF entering and leaving the cranium during the cardiac cycle provides an estimate of the intracranial volume change, and the pressure difference is estimated using the derivative of the CSF velocities.	During scan, approximately 30 minutes
Primary	Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture	The CSF pressure measured at lumbar puncture (LP), is 100-180 mm of H2O (8-15 mm Hg) with the patient lying on the side and 200-300 mm with the patient sitting up.	During lumbar procedure, up to 2 hours
Secondary	Change in Intracranial Pressure Estimated With MR Technique	Description: assessment of change in estimated ICP prior to and following standard-of-care epidural patching; and (2) evaluate changes in diameter and flow velocity through the transverse dural venous sinus prior to and following epidural blood patching.	Baseline, 24 hours
Secondary	Change in Caliber to the Transverse Venous Sinus Caliber	Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.	Baseline, 24 hours
Secondary	Change in Flow Velocity Through the Transverse Dural Venous Sinus	Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography	Baseline, 24 hours