Back to resultsNon-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
Primary Purpose
Intracranial Hypotension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI algorithm
Lumbar puncture
Epidural patching
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial Hypotension
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.)
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRICP method
Arm Description
MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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
Full Information
NCT ID
NCT03041441
First Posted
February 1, 2017
Last Updated
July 10, 2020
Sponsor
Duke University
Collaborators
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT03041441
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
October 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypotension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRICP method
Arm Type
Experimental
Arm Description
MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure.
Intervention Type
Device
Intervention Name(s)
MRI algorithm
Intervention Description
MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion
Intervention Type
Procedure
Intervention Name(s)
Lumbar puncture
Intervention Description
Lumbar puncture according to the standard-of-care treatment plan.
Intervention Type
Procedure
Intervention Name(s)
Epidural patching
Intervention Description
Epidural patching will be performed to the standard-of -care treatment plan
Primary Outcome Measure Information:
Title
Intracranial Pressure Measurements Estimated by the MRICP Technique.
Description
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.
Time Frame
During scan, approximately 30 minutes
Title
Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture
Description
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.
Time Frame
During lumbar procedure, up to 2 hours
Secondary Outcome Measure Information:
Title
Change in Intracranial Pressure Estimated With MR Technique
Description
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.
Time Frame
Baseline, 24 hours
Title
Change in Caliber to the Transverse Venous Sinus Caliber
Description
Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.
Time Frame
Baseline, 24 hours
Title
Change in Flow Velocity Through the Transverse Dural Venous Sinus
Description
Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography
Time Frame
Baseline, 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kranz, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
We'll reach out to this number within 24 hrs