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New procedure aims to stop debilitating headaches from spinal fluid leaks

NCT ID NCT05922514

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests a procedure called transvenous embolization to treat spontaneous intracranial hypotension, a condition where spinal fluid leaks cause severe headaches. Researchers at Mayo Clinic will enroll 200 people with confirmed CSF-venous fistulas. The goal is to see if blocking the leak with an embolic agent can reduce headache impact and improve MRI findings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transvenous embolization of cerebrospinal fluid-venous fistula
What this could lead to
If this procedure works, it could point toward a standard treatment for spontaneous intracranial hypotension caused by CSF-venous fistulas, potentially relieving severe headaches.
What could go wrong
This is an early registry study with only 200 participants, so results may not apply to everyone. The procedure involves risks like bleeding or infection, and it may not fully resolve symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

intracranial hypotension spontaneous intracranial hypotension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spontaneous intracranial hypotension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic Minnesota

    RECRUITING

    Rochester, Minnesota, 55905, United States

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