RecruitingNot Applicable

A Clinical Registry of Spontaneous Intracranial Hypotension

United States200 participantsStarted 2023-06-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Change in Headache Impact Test (HIT-6)

Timeframe: Baseline, 3 months, 1 year, 1.5 years, 2 years

Change in Bern SIH MRI Score

Timeframe: Baseline, 3 months, 1 year, 1.5 years, 2 years

Trial details

NCT IDNCT05922514

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

Theresa Nielson

507-422-0743 Nielson.Theresa@mayo.edu

View on ClinicalTrials.gov More Spontaneous Intracranial Hypotension trials