Registry for patients with spontaneous intracranial hypotension
Spontaneous Intracranial Hypotension Registry
Mayo Clinic · NCT05922514
This study is trying to see if a treatment called paraspinal vein embolization can help people with spontaneous intracranial hypotension who have specific fluid leaks in their brain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05922514 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on patients diagnosed with spontaneous intracranial hypotension (SIH) who have confirmed cerebrospinal fluid-venous fistulas. By utilizing imaging techniques such as digital subtraction myelography (DSM) and CT myelography (CTM), the study seeks to assess the efficacy of paraspinal vein embolization as a treatment option. The findings will help inform the design of future clinical trials targeting this condition. Participants will be monitored for their responses and outcomes over a specified follow-up period.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with SIH who have imaging-confirmed CSF-venous fistulas.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from spontaneous intracranial hypotension.
How similar studies have performed: While this approach is being explored, the efficacy of paraspinal vein embolization for SIH has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Waleed Brinjikji, MD — Mayo Clinic
- Study coordinator: Theresa Nielson
- Email: Nielson.Theresa@mayo.edu
- Phone: 507-422-0743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spontaneous Intracranial Hypotension