A Clinical Registry of Spontaneous Intracranial Hypotension
Spontaneous Intracranial Hypotension Registry
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2023
CompletedFirst Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
December 3, 2025
November 1, 2025
3 years
June 19, 2023
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Headache Impact Test (HIT-6)
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.
Baseline, 3 months, 1 year, 1.5 years, 2 years
Change in Bern SIH MRI Score
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).
Baseline, 3 months, 1 year, 1.5 years, 2 years
Secondary Outcomes (2)
Change in Pain Numerical Rating Scale (NRS)
Baseline, 3 months, 1 year, 1.5 years, 2 years
Change in Migraine Disability Assessment (MIDAS)
Baseline, 3 months, 1 year, 1.5 years, 2 years
Study Arms (2)
Group 1 Baseline, 3 months, 1 year, 1.5 years, and 2 years Questionnaires
170 participants with BERN imaging score with completion of baseline, 3 months, 1 year, 1.5 years, and 2 years questionnaires being : headache impact test (HIT-6), migraine disability assessment test (MIDAS), pain numerical rating scale (NRS), and spontaneous intracranial hypotension symptom severity scale (SIHSS). Each participant will keep a daily headache diary for 90 days.
Group 2 Baseline, 7 days and 3 month, 1 year, 1.5 years, and 2 years Questionnaires
30 participants with BERN imaging score with completion of baseline, 7 days, 3 months, 1 year, 1.5 years, and 2 years questionnaires being : headache impact test (HIT-6), migraine disability assessment test (MIDAS), pain numerical rating scale (NRS), and spontaneous intracranial hypotension symptom severity scale (SIHSS). Each participant will keep a daily headache diary for 90 days.
Interventions
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.
Eligibility Criteria
Patients being seen at Mayo Clinic in Rochester, Minnesota, for spontaneous intracranial hypotension (SIH) treatment evaluation by a neurologist with expertise in SIH. Patients would then be scheduled to meet with vascular radiology interventionalist for treatment (discussion and treatment(s) planning/scheduling purposes per standard of care. Patients would then speak with the study's coordinator to see if they would be interested to participant with and enroll in this study prior to SIH treatment.
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Waleed Brinjikji, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2023
First Posted
June 28, 2023
Study Start
June 18, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share