Spontaneous Intracranial Hypotension
Conditions
Brief 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.
Interventions
PROCEDURETransvenous 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.
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Impact Test (HIT-6) | Baseline, 3 months, 1 year, 1.5 years, 2 years | HIT-6 is a 6-item validated headache assessment tool designed to provide a global measure of headache impact in social functioning, role functioning, vitality, cognition, psychological distress, and severity of headache. Total score ranges 36-78: 36-49: little or no impact; 50-55 some impact; 56-59 substantial impact; \>60 severe impact. |
| Change in Bern SIH MRI Score | Baseline, 3 months, 1 year, 1.5 years, 2 years | The Bern SIH MRI score is a validated 9-point score assessing the severity of imaging finding suggestive of SIH. Calculated by adding the individual components for a score range of 0-9. Classified as low, intermediate, or high probability of having a CSF leak based on total Bern SIH score of 2 points or fewer (low), 3-4 points (intermediate), or 5 points or more (high). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Numerical Rating Scale (NRS) | Baseline, 3 months, 1 year, 1.5 years, 2 years | Subjects are asked to rate pain intensity in the past 7 days using a scale of 0 is no pain and 10 is the worst imaginable pain. |
| Change in Migraine Disability Assessment (MIDAS) | Baseline, 3 months, 1 year, 1.5 years, 2 years | MIDAS 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21+ severe disability. |
Countries
United States
Contacts
CONTACTGerard El Hajj, M.D.
CONTACTTheresa Nielson
PRINCIPAL_INVESTIGATORWaleed Brinjikji, MD
Mayo Clinic
Outcome results
None listed