Coiling lumbar veins to treat chronic headaches caused by Nutcracker physiology
Official title: Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients With Nutcracker Physiology and Retrograde Lumbar Vein Flow With Epidural Venous Plexus Enhancement
Run by Mayo Clinic · NCT06077747 · Data updated 2026-11-12
This study is testing if a new procedure that coils a vein in the lower back can help adults with chronic headaches caused by Nutcracker physiology feel better when other treatments haven't worked.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Status | Recruiting |
| Started | September 17, 2024 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06077747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults experiencing daily headaches for over three months, characterized by pressure sensations and worsened in certain positions, who have not found relief from standard headache medications.
✕Probably not a fit
Patients with evidence of disc edema or significant abnormalities in their lab results may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and feasibility of coiling the lumbar vein as a treatment for chronic headaches in patients with Nutcracker physiology. Participants, aged 18 and older, undergo extensive evaluations by headache specialists and neuro-ophthalmologists to confirm their condition and rule out secondary causes of headaches. Eligible patients will have chronic headaches characterized by pressure sensations and will have previously tried various headache treatments without success. The study aims to assess the effectiveness of this novel intervention in alleviating headache symptoms.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic headaches that have not responded to conventional therapies.
How similar studies have gone: While this approach is novel, similar studies exploring interventions for chronic headaches have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Daily headache from onset lasting \> 3 months. * Headache described as pressure sensation. * Headache worsened in the Trendelenburg position. * Exposed to CSF pressure/volume lowering medications. * Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response. * Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications. * MRI demonstrates that Nutcracker physiology is present. * Decreased SMA angle, renal vein narrowing, decreased AMD. * Retrograde lumbar vein flow and early EVP enhancement. * Ability to understand study procedures and to comply with them for the entire length of the study. * Negative pregnancy test. Exclusion Criteria: * Evidence of disc edema. * Positive urinalysis for hematuria or proteinuria. * Abnormal CBC or CMP. * MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.
Where it's running
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Mayo Clinic Florida
Jacksonville, Florida, United States Recruiting
Study contacts
- Principal investigator: Zlatko Devcic, MD — Mayo Clinic
- Study coordinator: Julia Santos
- Email: Santos.Julia@mayo.edu
- Phone: 904-953-3280
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.