A Clinical Registry of Spontaneous Intracranial Hypotension
Spontaneous Intracranial Hypotension Registry
Mayo Clinic
200 participants
Jun 18, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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).
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Interventions
Transvenous embolization of a cerebrospinal fluid-venous fistula performed via percutaneous venous access under fluoroscopic guidance. The procedure involves catheterization of the paraspinal or epidural venous system draining the fistula and delivery of an embolic agent to occlude the pathological venous outflow and eliminate CSF egress. The goal is to achieve durable fistula occlusion and resolution of spontaneous intracranial hypotension symptoms.
Locations(1)
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NCT05922514