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Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology

Recruiting

Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients With Nutcracker Physiology and Retrograde Lumbar Vein Flow With Epidural Venous Plexus Enhancement

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion. All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments.

What is being tested

Sponsor: Mayo Clinic · Participants: 4 · Started: Sep 17, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06077747

Locations in the U.S.

FloridaMayo Clinic Florida, Jacksonville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.