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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Duke University

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041441


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
University of Miami
Investigators
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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.

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

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