NCT03041441

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Hypotension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-14
• Primary completion: 2019-10-25
• Completion: 2019-10-26
• First posted: 2017-02-02
• Last updated: 2020-07-28
• Results posted: 2020-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study