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A Clinical Registry of Spontaneous Intracranial Hypotension

Spontaneous Intracranial Hypotension Registry

Who can join

Ages 18 and older · All sexes

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).

About the study

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.

What is being tested

• Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula (procedure)

Sponsor: Mayo Clinic · Participants: 400 · Started: Jun 18, 2023

Contact the study team

• Gerard El Hajj, M.D. · Phone: 507-255-2860
• Theresa Nielson · Phone: 507-422-0743

Official record on ClinicalTrials.gov — NCT05922514

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.