Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05922514

Conditions

Spontaneous Intracranial Hypotension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

Study Details

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.

Conditions

Spontaneous Intracranial Hypotension

Study ID

NCT05922514

Start date

Jun 18, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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 Cerebrospinal Fluid-Venous Fistula

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.

Primary outcome measure

  • Change in Headache Impact Test (HIT-6) [ Time Frame: Baseline, 3 months, 1 year, 1.5 years, 2 years ]
  • Change in Bern SIH MRI Score [ Time Frame: Baseline, 3 months, 1 year, 1.5 years, 2 years ]

Central Contacts and Locations

Central contacts

Gerard El Hajj, M.D.

507-255-2860ElHajj.Gerard@mayo.edu

Theresa Nielson

507-422-0743Nielson.Theresa@mayo.edu

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Theresa A Nielson

507 422 0743nielson.theresa@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-12.