A Clinical Registry of Spontaneous Intracranial Hypotension

Recruiting now

Conditions studied: Spontaneous Intracranial Hypotension

In brief

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.

Key facts

Study ID

NCT05922514

Run by

Mayo Clinic

People needed

200

Starts

2023-06-18

Expected to finish

2026-07-01

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Mayo Clinic Minnesota — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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