A Clinical Registry of Spontaneous Intracranial Hypotension
ConditionSpontaneous Intracranial Hypotension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov