A Clinical Registry of Spontaneous Intracranial Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula.
- Who it may be relevant to
- Registry conditions: Spontaneous Intracranial Hypotension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Spontaneous Intracranial Hypotension Registry
Overview
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.
Interventions
- Procedure Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula
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.
Primary outcome measures
- Change in Headache Impact Test (HIT-6) [Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years]
- Change in Bern SIH MRI Score [Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years]
Secondary outcome measures (2)
- Change in Pain Numerical Rating Scale (NRS) [Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years]
- Change in Migraine Disability Assessment (MIDAS) [Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05922514 · 21-006331