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RecruitingNot ApplicableNCT06077747

Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology

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

Sponsor

Mayo Clinic

Enrollment

4 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic HeadacheNutcracker Phenomenon, RenalNutcracker Syndrome, Renal

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria4

  • 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.

Interventions

PROCEDURECoil Embolization of the Lumbar Vein

Catheter based venography will first confirm Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus congestion. The lumbar vein will then be coil embolized.

Locations(1)

Mayo Clinic Florida

Jacksonville, Florida, United States

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NCT06077747