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NCT Number: NCT05922514

A Clinical Registry of Spontaneous Intracranial Hypotension

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.

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Key information

Conditions

Spontaneous Intracranial Hypotension Brain Diseases Central Nervous System Diseases Intracranial Hypotension Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Theresa A Nielson

CONTACT

[email protected]

507 422 0743

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transvenous Embolization of Cerebrospinal Fluid-Venous Fistula

Procedure

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 outcomes

  1. Change in Headache Impact Test (HIT-6)

    Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years

    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.

  2. Change in Bern SIH MRI Score

    Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years

    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).

Secondary outcomes

  1. Change in Pain Numerical Rating Scale (NRS)

    Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years

    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.

  2. Change in Migraine Disability Assessment (MIDAS)

    Time frame: Baseline, 3 months, 1 year, 1.5 years, 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gerard El Hajj, M.D.

CONTACT

[email protected]

507-255-2860

Theresa Nielson

CONTACT

[email protected]

507-422-0743

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Spontaneous Intracranial Hypotension Registry

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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