NCT05922514 A Clinical Registry of Spontaneous Intracranial Hypotension
| NCT ID | NCT05922514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Spontaneous Intracranial Hypotension |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-06-18 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-06-18 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Waleed Brinjikji, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05922514 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spontaneous Intracranial Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05922514 currently recruiting?
Yes, NCT05922514 is actively recruiting participants. Contact the research team at Nielson.Theresa@mayo.edu for enrollment information.
Where is the NCT05922514 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05922514 clinical trial?
NCT05922514 is sponsored by Mayo Clinic. The principal investigator is Waleed Brinjikji, MD at Mayo Clinic. The trial plans to enroll 200 participants.