Registry for patients with spontaneous intracranial hypotension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic Minnesota
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Waleed Brinjikji, MD — Mayo Clinic
• Study coordinator: Gerard El Hajj, M.D.
• Email: ElHajj.Gerard@mayo.edu
• Phone: 507-255-2860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two CT myelography methods for detecting CSF-venous fistulas in SIH

  This study tests whether the photon counting detector CT myelography (PCD-CTM) can find CSF-venous fistulas in spontaneous intracranial hypotension patients better than the standard energy integrating detector CT myelography (EID-CTM).

  Recruiting Duke University · Durham, North Carolina · NCT07582744

• Greater occipital nerve block to relieve headaches from spontaneous intracranial hypotension

  This will try a bilateral ultrasound-guided greater occipital nerve block in adults with spontaneous intracranial hypotension to see if it quickly reduces upright headache.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT06374524

• Catheter ablation for AF after spontaneous intracranial hemorrhage: SAFER-AF

  This study tests whether catheter ablation can offer better long-term outcomes than usual care for adults with atrial fibrillation who recently had a spontaneous intracranial hemorrhage.

  Recruiting at 2 sites Beijing Anzhen Hospital · Hefei, Anhui and 6 other locations · NCT07316270

• AI-guided robotic minimally invasive neurosurgery for intracerebral hemorrhage (RAINBOW-ICH)

  This trial will test whether AI-assisted, robotic-guided minimally invasive surgery helps adults with spontaneous intracerebral hemorrhage (including basal ganglia, intraventricular, and brainstem types) recover better than conventional care.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07205263

• Evaluating emergency surgery for severe brain hemorrhage patients on long-term antiplatelet treatment

  This study is trying to see if emergency surgery can help people with severe brain bleeding who are taking blood-thinning medications and how safe it is for them.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT05975398

• Comparing stent implantation to medical therapy for idiopathic intracranial hypertension

  This study is testing whether putting in a stent helps people with idiopathic intracranial hypertension feel better compared to just using medication.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT05707442

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.