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
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Hypotension||Device: MRI algorithm Procedure: Lumbar puncture Procedure: Epidural patching||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041441
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Peter Kranz, MD||Duke University|