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Completed

NCT Number: NCT03041441

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

MRI algorithm

Device

MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion

Lumbar Puncture

Procedure

Lumbar puncture according to the standard-of-care treatment plan.

Epidural patching

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of Miami

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2017
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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