NCT05922514Recruiting
A Clinical Registry of Spontaneous Intracranial Hypotension
Mayo Clinic
Start Date
6/18/2023
Completion Date
7/1/2026
Summary
The purpose of this research is to determine the efficacy of paraspinal vein embolization for treatment of digital subtraction myelography (DSM) or CT myelography (CTM) confirmed cerebrospinal fluid (CSF)-venous fistulas so that researchers can inform the development and design of future clinical trials of this technique.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Study subjects will be patients who meet the International Classification of Headache - Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH or the Schievink criteria with imaging confirmed CSF-venous fistulas on DSM or CTM.
* Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
* Negative urine or serum pregnancy test at time of study consent and three-months.
Exclusion Criteria:
* Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy).
* Inability to provide informed consent.
* Expected inability to complete the follow-up assessment.
* Current pregnancy or breast-feeding during study enrollment (from consent to study conclusion approximately 90-days).
Interventions
PROCEDURE
Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula
Conditions
Spontaneous Intracranial Hypotension
Locations
Mayo Clinic Minnesota
Rochester, Minnesota 55905
United States