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


Description

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.This is a feasibility, non-randomized, non-blinded clinical trial enrolling patients who are at least 18 years of age for the treatment of chronic headache in the setting of Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus enhancement. Patients are initially evaluated by a fellowship trained headache neurologist to obtain a detailed headache history, VAS score, MIDAS score, and physical examination. They are also evaluated by a neuro ophthalmologist with fundoscopic examination to assess for disc edema. A lab work-up is performed including complete blood count,

Trial Eligibility

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.

Study Info

Organization

Mayo Clinic


Primary Outcome

Change in headache pain


Outcome Timeframe 1,3,7,14, and 28 days after the procedure and then monthly for 17 months

NCTID NCT06077747

Phases NA

Primary Purpose TREATMENT

Start Date 2024-09-17

Completion Date 2027-09

Enrollment Target 4

Interventions

PROCEDURE Coil Embolization of the Lumbar Vein

Locations Recruiting

Mayo Clinic Florida

United States, Florida, Jacksonville


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