A Clinical Registry of Spontaneous Intracranial Hypotension

Spontaneous Intracranial Hypotension Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Intracranial Hypotension
• Intervention / Treatment: Procedure: Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Theresa Nielson; Phone Number: 507-422-0743; Email: Nielson.Theresa@mayo.edu
• Study Contact Backup: Name: Gerard El Hajj, M.D.; Phone Number: 507-255-2860; Email: ElHajj.Gerard@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota
      • Contact: Theresa A Nielson; Phone Number: 507 422 0743; Email: nielson.theresa@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients being seen at Mayo Clinic in Rochester, Minnesota, for spontaneous intracranial hypotension (SIH) treatment evaluation by a neurologist with expertise in SIH. Patients would then be scheduled to meet with vascular radiology interventionalist for treatment (discussion and treatment(s) planning/scheduling purposes per standard of care. Patients would then speak with the study's coordinator to see if they would be interested to participant with and enroll in this study prior to SIH treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.
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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Headache Impact Test (HIT-6)	HIT-6 is a 6-item validated headache assessment tool designed to provide a global measure of headache impact in social functioning, role functioning, vitality, cognition, psychological distress, and severity of headache. Total score ranges 36-78: 36-49: little or no impact; 50-55 some impact; 56-59 substantial impact; >60 severe impact.	Baseline, 3 months, 1 year, 1.5 years, 2 years
Change in Bern SIH MRI Score	The Bern SIH MRI score is a validated 9-point score assessing the severity of imaging finding suggestive of SIH. Calculated by adding the individual components for a score range of 0-9. Classified as low, intermediate, or high probability of having a CSF leak based on total Bern SIH score of 2 points or fewer (low), 3-4 points (intermediate), or 5 points or more (high).	Baseline, 3 months, 1 year, 1.5 years, 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Numerical Rating Scale (NRS)	Subjects are asked to rate pain intensity in the past 7 days using a scale of 0 is no pain and 10 is the worst imaginable pain.	Baseline, 3 months, 1 year, 1.5 years, 2 years
Change in Migraine Disability Assessment (MIDAS)	MIDAS 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21+ severe disability.	Baseline, 3 months, 1 year, 1.5 years, 2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Waleed Brinjikji, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypotension
• Other Study ID Numbers: 21-006331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No