Actively Recruiting
A Clinical Registry of Spontaneous Intracranial Hypotension
Led by Mayo Clinic · Updated on 2025-12-03
200
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Registry of Spontaneous Intracranial Hypotension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with spontaneous intracranial hypotension meeting International Classification of Headache Disorders 3rd Edition or Schievink criteria
- Imaging confirmation of cerebrospinal fluid-venous fistulas by digital subtraction myelography or CT myelography
- Clinically prescribed contrast-enhanced MRI positive for spontaneous intracranial hypotension
- Negative urine or serum pregnancy test at consent and at three months
You will not qualify if you...
- Contraindication or inability to undergo the embolization procedure, such as severe contrast allergy
- Inability to provide informed consent
- Expected inability to complete follow-up assessments
- Current pregnancy or breastfeeding during study enrollment and follow-up period (approximately 90 days)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
T
Theresa Nielson
CONTACT
G
Gerard El Hajj, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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