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

• ClinicalTrials.gov Identifier: NCT03041441
• Recruitment Status: Completed
• First Posted: February 2, 2017
• Results First Posted: July 28, 2020
• Last Update Posted: July 28, 2020
• Sponsor: Duke University
• Collaborator: University of Miami
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Intracranial Hypotension	Device: MRI algorithm; Procedure: Lumbar puncture; Procedure: Epidural patching	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
• Actual Study Start Date: September 14, 2017
• Actual Primary Completion Date: October 25, 2019
• Actual Study Completion Date: October 26, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: MRICP method; 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.

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.; Procedure: Epidural patching; Epidural patching will be performed to the standard-of -care treatment plan

Outcome Measures

Primary Outcome Measures :

1. Intracranial Pressure Measurements Estimated by the MRICP Technique. [ Time Frame: During scan, approximately 30 minutes ]
   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.
2. Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture [ Time Frame: During lumbar procedure, up to 2 hours ]
   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 :

1. Change in Intracranial Pressure Estimated With MR Technique [ Time Frame: Baseline, 24 hours ]
   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.
2. Change in Caliber to the Transverse Venous Sinus Caliber [ Time Frame: Baseline, 24 hours ]
   Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.
3. Change in Flow Velocity Through the Transverse Dural Venous Sinus [ Time Frame: Baseline, 24 hours ]
   Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

University of Miami

Investigators

• Principal Investigator: Peter Kranz, MD; Duke University

  Study Documents (Full-Text)

Documents provided by Duke University:

Study Protocol  [PDF] December 16, 2019

No Statistical Analysis Plan (SAP) exists for this study.

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03041441
• Other Study ID Numbers: Pro00078211
• First Posted: February 2, 2017
• Results First Posted: July 28, 2020
• Last Update Posted: July 28, 2020
• Last Verified: July 2020

• 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

Additional relevant MeSH terms:

Intracranial Hypotension; Hypotension; Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases